US20080197145A1 - Method for Dispensing Ophthalmic Fluid - Google Patents

Abstract

An ophthalmic dispenser and method of filling and dispensing fluid stored therein. The dispenser includes a rigid housing defining a fluid-receiving chamber, a flexible bladder receivable within the fluid-receiving chamber, a pump coupled in fluid communication with the fluid-receiving chamber, and a nozzle having a valve defining an annular, axially-extending valve seat, an outlet aperture coupled in fluid communication between the valve seat and the pump, and a flexible valve cover extending about the valve seat and forming an annular, axially-extending interface therebetween. The valve interface is connectable in fluid communication with the outlet aperture, and at least part of the valve cover is movable between (i) a normally closed position with the valve cover engaging the valve seat to close the interface and form a fluid-tight seal therebetween, and (ii) an open position with at least part of the valve cover spaced away from the valve seat in response to pumped fluid flowing through the outlet aperture at a pressure greater than a valve opening pressure to allow the passage of pressurized fluid therebetween. The rigid housing is mountable within a cartridge which, in turn, is mountable within a dispenser housing including an eyelid depressor and a trigger for simultaneously actuating the eyelid depressor and pump.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This patent application is a divisional of U.S. patent application Ser. No. 10/691,270, filed Oct. 21, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 10/001,745, filed Oct. 23, 2001, entitled “Fluid Dispenser Having A Rigid Vial And Flexible Inner Bladder,” which claims the benefit of similarly-entitled U.S. Provisional Application Ser. No. 60/242,595, filed Oct. 23, 2000, and U.S. Provisional Application Ser. No. 60/242,974, filed Oct. 24, 2000, each of which is hereby expressly incorporated by reference as part of the present disclosure. This patent application also claims the benefit of U.S. Provisional Application Ser. No. 60/443,524, filed Jan. 28, 2003, entitled “Fluid Dispenser Having A Rigid Vial And Flexible Inner Bladder”, and similarly-entitled U.S. Provisional Patent Application Ser. No. 60/420,334, filed Oct. 21, 2002, each of which is hereby expressly incorporated by reference as part of the present disclosure.
FIELD OF THE INVENTION
• The present invention relates generally to dispensers and to methods for storing and dispensing fluids or other substances, and to methods for manufacturing, distributing, and/or selling such dispensers, including but not limited to, dispensers having a rigid vial, a flexible bladder disposed within the rigid vial and defining a chamber between the flexible bladder and rigid vial for receiving therein a fluid or other substance, and a nozzle and pump assembly coupled in fluid communication with chamber for dispensing fluids or other substances therefrom.
BACKGROUND INFORMATION
• Typical fluid dispensers include a container defining therein a chamber for receiving a fluid to be dispensed, a nozzle and pump assembly mounted on the container, and a dip tube extending downwardly from the nozzle into the chamber for pumping the fluid from the bottom of the chamber, through the dip tube, and out of the dispenser. Other known dispensers include a vial and a flexible bladder received within the vial. For example, U.S. Pat. No. 6,062,430 to Fuchs shows in FIG. 1 a dispensing container with variable volume compensation including a bottle-shaped vessel 2 in the form of a thin-walled, hollow body made from soft elastic plastic, and a reception container 15 formed of a wrinkle film encapsulated within the vessel body 2.
• One of the drawbacks associated with typical prior art fluid dispensers is that the fluid chamber(s) are not maintained in a substantially airless condition throughout the storage, shelf life and/or usage of the dispenser. For example, the nozzles and/or valves used in typical prior art dispensers frequently are incapable of maintaining the dispenser in a hermetically sealed condition. Such nozzles and/or valves allow the passage of air or other gases therethrough and into contact with the medicament or other substance contained within the fluid chamber(s). In addition, such nozzles and/or valves frequently allow vapor loss therethrough either during the storage, shelf life or usage of the dispensers.
• Another drawback associated with prior art dispensers is that the materials of construction may undergo creep that, in turn, causes seals formed within the dispensers to leak. Many medicaments are maintained in storage and/or on store shelves for at least several, and in some instances, many months. During transportation and storage, the dispensers can be subjected to varying atmospheric conditions involving large variations in atmospheric temperature, pressure and/or humidity. As a result, the dispensers are frequently subjected to substantial differential thermal expansion and/or contraction that, in turn, cause the materials of construction to undergo creep. The seals and other components of such prior art dispensers typically are not designed to address such creep, and as a result, the dispensers develop leaks or otherwise allow air ingress and/or vapor loss when subjected to such long periods of storage or varying atmospheric conditions. For example, some polyethylene dispensers have been known to lose between about 10% to about 25% of the weight of their contents during storage. Such weight loss is believed to be due to vapor loss from the medicament or other fluid-containing chambers through the polyethylene walls of the dispensers and/or through leaks otherwise created in the seals or other structural interfaces of the containers. The vapor loss is typically offset by air ingress into the chambers. Vapor loss and/or air ingress is particularly problematic for dispensers containing medicaments, such as pharmaceutical preparations or vaccines, because they tend to dilute each predetermined dosage of the medicament dispensed from the container, and/or cause the dispenser to dispense inconsistent concentrations of medicament from one dose to the next.
• Yet another disadvantage associated with prior art dispensers is that because they cannot reliably maintain the medicament or other substance contained therein in an airtight condition, they cannot be used for either multiple dose applications or preservative-free formulations. The use of single dose dispensers can be substantially more expensive than multiple dose dispensers. In addition, the preservatives used in many medicaments, such as pharmaceutical preparations and vaccines, can cause adverse reactions in patients and/or dilute the effect of the medicament on the patient.
• Another drawback of prior art dispensers is that the ullage or “dead space” inherent in such dispensers allows sediment build-up. Many medicaments and other formulations contained within such dispensers are suspensions. The ullage or dead space in the prior art dispensers allows the solutes or other solid components of such suspensions to form sediment therein. Such settling of the suspensions dilutes the medicaments or other substances contained within the dispensers and, in turn, alters the medicament and/or the concentration of medicament in each patient dose.
• Another drawback associated with many prior art dispensers is that they can only dispense the medicament or other substance contained therein in an upright or other single orientation. This drawback prevents such dispensers from being used effectively in other orientations, such as upside down. In addition, because such dispensers do not maintain the medicament or other substance contained therein in an airless condition, they cannot be used in low gravity environments, such as outer space.
• Dispensers for storing and dispensing fluids (or other substances) are used in a variety of applications. One such application is that of eye treatment. Indeed, numerous dispensers have been developed for dispensing medicament to an eye. Some of these dispensers consist of a flexible vial that dispenses medicament when the side walls of the vial are squeezed. Such dispensers are commonly referred to as “eye droppers”. Less common, are dispensers that include a pump type delivery system.
• Various difficulties can arise with respect to properly applying medicament to the eye. For example, many people encounter difficulty in applying drops to their eyes. The eye is a very sensitive body part and individuals find it difficult to control reflexive blinking when applying drops thereto. Also, some users have trouble positioning the tip of a dropper bottle over the eye. Others have difficulty holding a dropper bottle steady or encounter difficulty in squeezing a bottle to apply a proper quantity. Moreover, it is often desirable to deliver medicament to a particular region of the eye. For example, when eye drops are applied to the surface of the eyeball, blinking and natural tear flow combine to dispel and/or dilute the medicament thereby limiting its effectiveness. Moreover, some medicaments can cause “red-eye” if delivered directly to the cornea area of the eyeball. On the other hand, if the medicament is delivered to the cul-de-sac of the conjunctiva, the medicament is less susceptible to blinking and tear flow and therefore remains effective for a longer period of time.
• Some dispensers have features adapted to address one or more of these difficulties. Examples of these types of features are an eyelid cover, an eyelid depressor, a pump type delivery system, and/or a trigger mechanism. The eyelid cover helps the user properly position the dispenser over the eye. The eyelid depressor helps expose the conjunctive cul-de-sac. A pump type delivery system helps deliver the medicament. A trigger mechanism provides the user with a convenient way to activate the delivery system.
• One drawback associated with such dispensers is that their cost can be more than otherwise would be desired. Moreover, even those who can afford such dispensers may forgo the extra features in favor of a less costly alternative. Consequently, it would be desirable to enable manufacturers of such dispensers to be able to offer less costly alternative(s) in order to reach all sectors of the market.
• Another drawback associated with these dispensers is that they can be bulkier than dispensers without such features, thereby making them less convenient to transport (e.g., carry in a pocket, ship, etc.) than is desired.
• Another drawback associated with these types of dispensers is that they are limited in regard to the amount of medicament (or other fluid) that is able to be stored in the dispenser. Although most (if not all dispensers) suffer from this drawback, the cost of certain dispensers may make it impractical to throw them away when empty. Thus, there may be a need to refill the chamber that holds the medicament. In many of these dispensers, the chamber is not readily accessible to the user, and consequently, impractical to refill. Some types of dispensers employ a replaceable cartridge. This solves the refill problem; however, the actuation mechanisms on such dispensers are less convenient to use than is currently desired.
• Another drawback associated with many of these types of dispensers is that a vacuum pump is needed in order properly fill and cap the chamber without spillage.
• Accordingly, it is an object of the present invention to overcome one or more of the above-described drawbacks or disadvantages of the prior art.
SUMMARY OF THE INVENTION
• The present invention is directed to a method for storing and dispensing a fluid. According to one aspect of the present invention, the method comprises the following steps: providing a plurality of cartridges for storing and dispensing fluid, the plurality of cartridges being substantially identical to one another and each having a vial, a pump, and a nozzle, the vial including an interior fluid receiving chamber defined therein, the pump being in fluid communication with the fluid receiving chamber for pumping a fluid received therein from the cartridge, and the nozzle being disposed in fluid communication with the pump for allowing the passage of the pumped fluid therethrough. The cartridge further includes a casing that retains the nozzle, the pump, and the vial arranged in that order along a longitudinal axis moving in a direction toward a posterior end of the cartridge, and an actuator operatively coupled to the pump. The method further comprises installing at least one of the plurality of cartridges in a dispenser having an actuator to operatively couple to the cartridge, wherein actuation of the actuator initiates dispensing, and using at least one of the cartridges to dispense fluid without installing the cartridge in a dispenser having an actuator to operatively couple to the cartridge.
• According to another aspect, the invention is directed to a method of storing and dispensing a fluid comprising the following steps: providing a plurality of cartridges for storing and dispensing fluid, the plurality of cartridges being substantially identical to one another and each having a vial, a pump, and a nozzle, the vial including an interior fluid receiving chamber defined therein, the pump being in fluid communication with the fluid receiving chamber for pumping a fluid received therein from the dispenser, and the nozzle being disposed in fluid communication with the pump for allowing the passage of the pumped fluid therethrough. The cartridge further having a casing that retains the nozzle, the pump, and the vial arranged in that order along a longitudinal axis moving in a direction toward a posterior end of the cartridge, and an actuator operatively coupled to the pump. The method further comprises providing a plurality of dispensers adapted to receive and operate the cartridges, the plurality of cartridges being substantially identical to one another and being capable of operation as a stand alone unit or in the dispenser. Further, the method comprises selling at least one of the cartridges in combination with at least one of the dispensers, and selling at least one of the cartridges without a dispenser.
• According to another aspect, the invention is directed to a method for filling a dispenser. The dispenser comprises a rigid housing defining a first fluid-receiving chamber, and a flange defining a second fluid-receiving chamber axially spaced relative to the first fluid receiving chamber and connectable in fluid communication therewith; a flexible bladder defining an axially-extending body portion receivable within the first fluid-receiving chamber of the housing, a first annular sealing surface, and a second annular sealing surface axially spaced on an opposite side of the first annular sealing surface relative to the axially-extending body portion and receivable within the flange of the housing; and a pump coupled in fluid communication with the first fluid-receiving chamber. The dispenser further comprises a nozzle including a valve, the valve comprising an annular, axially-extending valve seat, an outlet aperture coupled in fluid communication between the valve seat and the pump, and a flexible valve cover extending about the valve seat and forming an annular, axially-extending interface therebetween, wherein the interface is connectable in fluid communication with the outlet aperture. At least part of the valve cover is movable between (i) a normally closed position with the valve cover engaging the valve seat to close the interface and form a fluid-tight seal therebetween, and (ii) an open position with at least part of the valve cover spaced away from the valve seat in response to fluid flowing through the outlet aperture at a pressure greater than a valve opening pressure to allow the passage of pressurized fluid therebetween. Further, at least one spring is drivingly connected to at least one of the pump and housing, wherein the spring moves at least one of the pump and housing relative to the other to actuate the pump. The method comprising the steps of: introducing a fluid into a first fluid-receiving chamber of a rigid housing and inserting a portion of a flexible bladder into the first fluid-receiving chamber such that the first fluid-receiving chamber is filled with fluid and at least part of a second fluid-receiving chamber defined by a flange connectable in fluid communication with the first fluid-receiving chamber is also filled with fluid. The method further comprises forming a first substantially fluid-tight seal between the first annular sealing surface of the bladder and the housing, forming a second substantially fluid-tight seal between the second annular sealing surface of the bladder and the flange such that the first fluid-receiving chamber is filled with fluid substantially without any gas therein, and the second fluid-receiving chamber is at least partially filled with fluid. In one embodiment, the method further comprises collapsing the bladder prior to its insertion into the first fluid-receiving chamber.
• Other objects and advantages of the various preferred embodiments of the present invention will become apparent in view of the following detailed description and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a partially broken-away, perspective view of an ocular treatment apparatus having a dispenser mounted therein in accordance with a preferred embodiment of the present invention.
• FIG. 1A is a view similar toFIG. 1 absent the dispenser.
• FIG. 1B is a perspective view of the ocular treatment apparatus ofFIG. 1.
• FIG. 1C is an exploded view, in perspective, of the ocular treatment apparatus ofFIG. 1B.
• FIG. 1D is an exploded view, in side elevation, of the ocular treatment apparatus ofFIG. 1B.
• FIG. 2 is a side elevational view, partly in section, illustrating in further detail the dispenser ofFIG. 1 including the pump assembly, vial and a bladder and wherein the pump assembly is disposed in a closed position.
• FIG. 3 is a view similar to that ofFIG. 2, although the dispenser is rotated 90° with respect to its orientation inFIG. 2, and the pump assembly is disposed in an extended position.
• FIG. 4 is a central cross-sectional view taken along a longitudinal axis of a piston of the pump assembly ofFIG. 1.
• FIG. 5 is a front elevational view of a tip of a nozzle of the pump assembly ofFIG. 1.
• FIG. 6 is a longitudinal cross-sectional view taken along line6-6 ofFIG. 5.
• FIG. 7 is a central cross-sectional view taken along a longitudinal axis of a slide or body of the pump assembly ofFIGS. 2 and 3 and forming essentially the compression zone.
• FIG. 8 is a central cross-sectional view taken along a longitudinal axis of a flexible pump cover of the pump assembly ofFIGS. 2 and 3, and illustrating the manner in which the pump cover extends from the tip of the nozzle to the rigid vial and is configured to allow reciprocal movement of the piston connected to the vial.
• FIG. 9 is a central, cross-sectional view taken along a longitudinal axis of the rigid vial of the dispenser ofFIGS. 2 and 3.
• FIG. 9A is an enlarged view of a portion of the vial ofFIG. 9 showing a rear mounting portion for receiving the bladder ofFIG. 10.
• FIG. 10 is a central, cross-sectional view taken along a longitudinal axis of the bladder of the dispenser ofFIGS. 2 and 3 showing in this configuration a three-ribbed structure provided to allow the bladder to collapse into a predetermined collapsed condition.
• FIG. 10A is an enlarged view of a portion of the bladder ofFIG. 10.
• FIG. 10B is a highly enlarged view of a portion of the bladder ofFIG. 10.
• FIG. 11 is a cross-sectional view taken along a transverse axis of the bladder ofFIG. 10.
• FIG. 12 is a schematical view showing, in cross section, another embodiment of the bladder of the dispenser ofFIGS. 2 and 3 disposed within the rigid vial and including elongated discontinuities or elongation buffers disposed in an outer wall of the bladder to facilitate the collapse of the arcs that pass through the chords of the respective arcs.
• FIG. 13 is a top plan view of the rear plug employed to close the rear end of the inner bladder by forming a sandwich-type structure between the rigid vial and rear plug to hermetically seal the dispenser ofFIGS. 2 and 3.
• FIG. 14 is a sectional view of the rear plug taken along line14-14 ofFIG. 13.
• FIG. 14A is an enlarged portion of the rear plug ofFIG. 14 showing further detail of an annular side wall of the plug.
• FIGS. 15A-C are sequential side elevational views, partly in section, showing the reduction in volume of fluid and corresponding expansion of the bladder in the full, half-full and empty conditions of the dispenser ofFIG. 1, respectively.
• FIGS. 16A-C are sequential side elevational views, partly in section, showing the steps of assembling the bladder to the vial during sterilization and filling of the dispenser ofFIGS. 2 and 3.
• FIG. 17 is a perspective view of another embodiment of a dispenser of the present invention.
• FIG. 18 is an end elevational view of the dispenser ofFIG. 17.
• FIG. 19 is a cross-sectional view of the dispenser ofFIGS. 17 and 18 taken along line19-19 ofFIG. 18.
• FIG. 20 is a cross-sectional view of the dispenser ofFIGS. 17 and 18 taken along line20-20 ofFIG. 18.
• FIG. 21 is a perspective view of the rear plug of the dispenser ofFIG. 17.
• FIG. 22 is cross-sectional view of the rear plug ofFIG. 21.
• FIG. 23 is a partial, enlarged cross-sectional view of the rear plug ofFIG. 21.
• FIG. 24 is a partial, cross-sectional view of the axially-extending and radially-projecting legs of the rear plug ofFIG. 21 illustrating the flexible bladder conformably engaging the legs in the predetermined collapsed condition.
• FIG. 25 is a partial, cross-sectional view of the legs of the rear plug and bladder illustrating the bladder in the expanded condition.
• FIG. 26 is a cross-sectional view of the flexible bladder of the dispenser ofFIG. 17.
• FIG. 27 is a partial, enlarged cross-sectional view of a portion of the flexible bladder ofFIG. 26.
• FIG. 28 is a front elevational view of the integral nozzle and slide of the dispenser ofFIG. 17.
• FIG. 29 is a cross-sectional view of the integral nozzle and slide taken along line29-29 ofFIG. 28.
• FIG. 30 is a side elevational view of the integral piston and rigid vial of the dispenser ofFIG. 17.
• FIG. 31 is a partial, cross-sectional view of the integral piston and rigid vial ofFIG. 30.
• FIG. 32 is a cross-sectional view of the flexible nozzle cover and bellows of the dispenser ofFIG. 17.
• FIG. 33 is a cross-sectional view of another embodiment of the dispenser of the present invention including a resealable portion on the flexible bladder for inserting a needle or like injection member therethrough to fill the dispenser with a medicament or other substance, and allowing the needle holes to be sealed by application of thermal energy thereto.
• FIG. 34A is a front-top perspective view of an ocular treatment apparatus according to another embodiment of the present invention.
• FIG. 34B is a side elevational view of the ocular treatment apparatus ofFIG. 34A.
• FIG. 34C is a front-bottom perspective view of the ocular treatment apparatus ofFIG. 34A.
• FIG. 35A is a perspective view of the ocular treatment apparatus ofFIG. 34A, with the housing in an open state.
• FIG. 35B is a side elevational view of the ocular treatment apparatus ofFIG. 34A, with the housing in the open state.
• FIG. 36 is an enlarged perspective view of a portion of the cartridge ofFIG. 35A.
• FIG. 37 is a partially exploded view, in perspective, of the ocular treatment apparatus ofFIG. 35A.
• FIG. 38 is a partially broken away, side elevational view of the cartridge ofFIG. 35A.
• FIG. 39A is a rear elevational view of the integral piston and vial ofFIG. 38.
• FIG. 39B is a rear-bottom perspective view of the integral piston and vial ofFIG. 38.
• FIG. 39C is a side elevational view of the integral piston and vial ofFIG. 38.
• FIG. 39D is a cross-sectional view of a portion of the integral piston and vial ofFIG. 38.
• FIG. 40A is a partially broken away, side elevational view of the ocular treatment apparatus ofFIG. 34A.
• FIG. 40B is a partially broken away, front-bottom perspective view of the ocular treatment apparatus ofFIG. 34A.
• FIG. 40C is a cross-sectional view of the ocular treatment apparatus ofFIG. 34A.
• FIG. 41A is a side elevational view, partly in section, showing another embodiment of the rigid vial and bladder, wherein the vial is in a filled and un-capped condition.
• FIG. 41B is a side elevational view, partly in section, showing the rigid vial and bladder ofFIG. 41A, wherein the vial is in a capped condition.
• FIG. 42 is a front-top perspective view, partially in phantom, of an ocular treatment apparatus according to another embodiment of the present invention.
• FIG. 43 is a partially exploded view, in perspective, of the ocular treatment apparatus ofFIG. 41.
• FIGS. 44A-44C are perspective views of the cartridge ofFIG. 41.
• FIG. 45 is an exploded view, in perspective, of the cartridge ofFIG. 41.
• FIG. 46 is a cross sectional view of the cartridge ofFIG. 41 with one embodiment of an eyelid depressor.
• FIGS. 47A-47D are views of another embodiment a storage and delivery system.
• FIG. 48 is a cross sectional view of the cartridge ofFIG. 41 with another embodiment of an eyelid depressor.
• FIG. 49 is a partially broken away, perspective view of an ocular treatment apparatus according to another aspect of the present invention.
• FIGS. 50A-50D are sequential side elevational views, partly in section, showing the operation of the ocular treatment apparatus ofFIG. 49 as progressively greater force is applied to the trigger.
• FIGS. 50E-50H are sequential side elevational views, partly in section, showing the operation of the ocular treatment apparatus ofFIG. 49 after the trigger is fully actuated and the trigger progressively returns to its initial state.
• FIG. 51 is a perspective view of the ocular treatment apparatus ofFIG. 49, with the housing in an open state.
• FIG. 52 is a partially exploded view, in perspective, of the ocular treatment apparatus ofFIG. 49.
• FIG. 53 is a partially exploded side elevational view, of the ocular treatment apparatus ofFIG. 49.
• FIG. 54 is an enlarged side elevational view of the cartridge ofFIG. 49 with an eyelid depressor releasably secured thereto, in accordance with another aspect of the present invention.
• FIG. 55 is a perspective view of the cartridge and eyelid depressor ofFIG. 54.
• FIGS. 56-57 are side elevational views of the cartridge ofFIG. 49 with an another embodiment of an eyelid depressor releasably secured thereto.
• FIG. 58 is a perspective view of the cartridge and eyelid depressor ofFIG. 56.
• FIG. 59 is a view of one embodiment of a nozzle, piston and vial that may be used in the cartridge ofFIG. 49.
• FIGS. 60A-60D are views of another embodiment of a nozzle, piston and vial that may be used in the cartridge ofFIG. 49.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
• InFIG. 1, there is shown anocular treatment apparatus8 that may be used in conjunction with a dispenser, shown generally at10, in accordance with the present invention. As seen inFIGS. 1 and 1A, thetreatment apparatus8 comprises ahousing12 that may be generally U-shaped in cross section, and defines aninterior cavity14 and aneye cover16. Atrigger18 is pivotably connected at oneend20 to thehousing12 via ahinge22, and includes at the other end anarm portion24 defining aslot25. As shown best inFIG. 1A, apin26 of awheel27 is fixedly secured within theslot25, and thewheel27 is rotatably mounted on the interior wall of thehousing12. As best seen inFIG. 1, thetrigger18 is elongated and comprises finger grooves28 for a comfortable fit with, e.g., a patient's hand. An approximately L-shapedspring arm30 is fixedly secured at one end to apost29 projecting inwardly from the interior wall of thehousing12, and the spring arm defines a knee or bent portion31 (shown in phantom) engaging an interior surface of thetrigger18, and afree end32 engageable with arim34 formed at one end of thedispenser10. Aneyelid depressor36 is pivotably mounted by ahinge38 to the end of thehousing12 adjacent to theeye cover16, and includes ahook40 fixedly secured to thewheel27 for pivotably moving the eyelid depressor upon actuating thetrigger18.
• In use, theeye cover16 is placed adjacent to the tissue surrounding the eye with theeyelid depressor36 engaging the tissue adjacent to the ocular cul-de-sac. Upon squeezing thetrigger18, theeyelid depressor36 rotates in the direction of thearrow41, and in turn moves the tissue adjacent to the eye to expose the ocular cul-de-sac. Rotation of theeyelid depressor36 is caused by thewheel27 which also uncovers anozzle42 formed at the adjacent end of thedispenser10. Simultaneously, thespring arm30 forces therim34 of thedispenser10 away from the fixednozzle42 to thereby prime the pump of the dispenser, as described in further detail below. Upon squeezing thetrigger18 and correspondingly extending thedispenser10 within thehousing12, thefree end32 of thespring arm30 eventually disengages itself from therim34 of the dispenser to thereby release the extended dispenser from the spring arm. As a result, due to the resiliency or spring-like nature of thenozzle42, as described further below, the extended dispenser contracts or moves back toward the nozzle and, in turn, releases a predetermined dosage of medicament (or other substance) from the nozzle and into the ocular cul-de-sac of the user's eye. Then, when the user removes theocular treatment apparatus8 from his or her eye and releases thetrigger18, thespring arm30 automatically returns to its original or resting position as shown inFIG. 1 with thefree end32 engaging therim34. The force exerted by thespring arm30 upon returning to its original position also rotatably drives thewheel27 in the direction opposite that of thearrow41 and, in turn, causes theeyelid depressor36 to return to its original position, as shown. The ocular treatment apparatus is then ready to dispense another predetermined dosage of medicament or other liquid contained therein.
• Other examples of ocular treatment apparatus that may employ thedispenser10 are described in U.S. Pat. Nos. 4,981,479 and 6,033,384, which are assigned to the assignee of the present invention and are hereby incorporated by reference as part of the present disclosure. Accordingly, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the dispensers of the present invention may be utilized in any of numerous different apparatus or systems to facilitate holding and dispensing medicaments or other fluids, liquids or other substances contained therein, such as nasal inhalers.
• Referring now toFIGS. 2 and 3, thedispenser10 is shown partly in cross section to illustrate the internal components thereof. Thedispenser10 is generally cylindrical in outer configuration and comprises apump assembly50, a generallyrigid vial52, and aflexible bladder54 disposed within amain fluid chamber55 of the vial. Thepump assembly50 comprises apiston56 for discharging predetermined doses of medicaments or other substances contained within thefluid chamber55, a slide orbody60 for slidably receiving therein the piston and defining a predetermined dosage chamber therebetween, and apump cover62 forming with a nozzle58 a one-way valve at the dispensing tip and a spring-like bellows for allowing either the piston or nozzle to be moved toward the other to eject a dose of medicament or other substance through the nozzle, and to force either the piston or the nozzle away from the other upon releasing the predetermined dose. Thenozzle58 hermetically seals the dispensing tip of the dispenser and ejects the pumped medicament or other substance therethrough.
• Referring now also toFIG. 4, thepiston56 may be composed of any durable and moldable material, such as a plastic substance and, preferably, the material is suitable for use in connection with medicaments. A suitable material is a low density polyethylene. Thepiston56 comprises abase portion64, anelongated portion66 extending from thebase portion64, and acentral bore68 which is in fluid communication with themain fluid chamber55. Thebase portion64 is generally disc-like in outer configuration, and comprises a connectingflange70, an annular mountingportion72, a firstannular groove74, and a secondannular groove76 spaced inwardly relative to the first annular groove and surrounding the inlet end of thecentral bore68. The connectingflange70 is configured to engage, e.g., in a snap-lock manner, thevial52 defining a correspondingly dimensioned mounting flange78 (FIG. 2). As shown inFIG. 2, the mountingportion72 and firstannular groove74 receive anannular flange80 andrib82, respectively, of thepump cover62 which is composed of a flexible material, as discussed in more detail below, and which thereby seals themain fluid chamber55 ofvial52. As further shown inFIG. 2, when thepiston56 is assembled to thevial52, the secondannular groove76 is located adjacent to themain fluid chamber55. The secondannular groove76 thereby functions to provide a capture area to receive any gas bubbles improperly disposed within the main fluid chamber and to prevent the bubbles from passing into thecentral bore68.
• As shown best inFIG. 4, theelongated portion66 comprises anannular groove84, a laterally-extendingbore86, and a terminal end defining areceptacle portion88. Theannular groove84 is configured to receive a seal90 (FIG. 2), such as an o-ring, for sealing the piston in contact with theslide60. The laterally extendingbore86 is in fluid communication with thecentral bore68 and terminates adjacent to an annularinterior surface92 of the slide60 (FIG. 3). As shown best inFIG. 4, thereceptacle portion88 comprises anannular wall94, a taperedportion95 extending between theannular wall94 and bore86, and apiston surface96 for stopping movement of thenozzle58 as described in more detail below in connection withFIGS. 5 and 6. Theannular wall94 defines a generally increasing outer diameter toward the distal end, and slidably engages the annularinterior surface92 of theslide60 as described in more detail below in connection withFIG. 7.
• As shown inFIG. 3, thepiston56 further includes two generally symmetrically-locatedhook portions97, and eachhook portion97 defines in combination with anouter surface101 of the piston56 arespective slot99. As described in more detail below in conjunction withFIG. 7, theslide60 is reciprocally disposed within theslots99 for allowing relative movement of the piston within the slide upon actuation of the pump.
• Referring now toFIGS. 5 and 6, thenozzle58 may be composed of any suitably durable, moldable, somewhat flexible material (in the configuration wherein the nozzle and body are made of one piece), such as a plastic material, and currently is composed of a material which has been found to be compatible with medicaments, such as those materials sold under the trademarks VELEX and LEXAN, both owned by the General Electric Company of Pittsfield, Mass. Thenozzle58 is preferably molded of one piece and comprises a truncated, conical-shapedbody portion98, and adisc portion100 disposed coaxially with the conical-shaped portion and extending radially therefrom. It will be recognized that the conical-shapedportion98 anddisc portion100 may be molded together or separately. The conical-shapedportion98 comprises a taperedouter surface102, a partialcentral bore104, and anengagement portion106. The partialcentral bore104 terminates at alever wall108 which is dimensioned and configured to allow flexing of the taperedouter surface102 in the direction of thearrow110. Theengagement portion106 is configured to mate with thereceptacle portion88 of thepiston56, described above in connection withFIG. 4, and comprises a truncated conical configuration terminating in anengagement surface112. As illustrated inFIGS. 2 and 3, when thepiston56 reaches the end of its stroke upon dispensing a predetermined dose, theengagement surface112 of the nozzle is received within theguide wall94 and engages thepiston surface96 to terminate further movement. It will be recognized that avariable stroke volume113 is defined between theengagement surface112 of thenozzle58 and thepiston surface96 of thepiston56. As illustrated inFIG. 3, the maximum stroke volume is defined by the maximum extension of theengagement surface112 from thepiston surface96.
• As shown inFIG. 6, thedisc portion100 comprises anannular mounting portion114 for affixably mounting thenozzle58 to thepump cover62 and slide60 (FIGS. 2 and 3), and also comprises aslot116 for the passage of fluid or other substances therethrough. The mountingportion114 comprises an annular thickenedportion118 and aneck portion120 disposed between a pair ofannular grooves122 and124. As shown inFIGS. 2 and 3, theannular groove122 is configured to engage arib126 of the pump cover62 (FIG. 8), and theannular slot124 is configured to engage a correspondingly configuredterminal end portion128 of the slide60 (FIG. 7). As shown inFIG. 6, theannular groove124 defines anannular crevice130, employed, e.g., for easing assembly of theslide60 to thenozzle58. Theslot116 is disposed adjacent to a flattened portion132 of the taperedouter surface102, and provides fluid communication from thevariable stroke volume113 through thedisc portion100 to the tapered outer surface.
• As illustrated inFIG. 7, theslide60 defines a tubular body and may be composed of a similar substance to that described above with respect to the nozzle58 (FIGS. 5 and 6). As described above and referring also toFIG. 2, theslide60 comprises an annularinside surface92 within which thepiston56 andengagement portion106 of thenozzle58 are disposed after assembly of thedispenser10. Theinside surface92 defines abore134 with aneck portion136 of reduced diameter disposed between afirst transition zone138 of relatively rapid increase in diameter, and asecond transition zone140 of relatively gradual increase in diameter. Referring now toFIG. 2, it will be understood that during relative movement of thenozzle58 and theslide60 away from thepiston56, theannular wall94 of the piston (FIG. 4) will engage the second transition zone140 (FIG. 7) in sealing engagement to thereby force fluid contained within thevariable stroke volume113 into theslot116 of the nozzle tip.
• With reference toFIG. 7 and as described above in connection withFIGS. 5 and 6, theslide60 defines aterminal end128 that includes anannular ridge142 configured to engage thecrevice130 of thenozzle58. As shown inFIG. 3, the opposite end of theslide60 defines aflange144 that is configured to engage thehook portion97 of thepiston56.
• FIG. 8 depicts a cross-sectional view of theflexible pump cover62. Theflexible pump cover62 may be composed of any durable, resilient and flexible material, such as an elastomeric material. Preferably, thepump cover62 is composed of a thermo-elastic material, such as a styrene-butadiene elastomer sold under the trademark KRATON by GLS of Illinois. Other suitable materials include polyvinylchloride, Santoprene™ and butyl rubber. Thepump cover62 comprises a mountingportion146, abellows portion148, and anozzle cover150 which cooperates with the slot116 (FIG. 6) to provide an elastic valve, as described further below in connection withFIG. 5. As described above in connection withFIG. 4, the mountingportion146 comprises anannular flange80 that fits within the mountinggroove72 adjacent to the mountingflange78 of the vial52 (FIG. 2). As shown inFIG. 8, therib82 defines in cross section a truncated conical shape corresponding to the configuration of theannular groove74 of the piston (FIG. 4). Because of the resilient nature of the material of thepump cover62, theannular flange80 may be slightly oversized in order to provide a resilient fit with thevial52 andpiston56 and thereby, in combination with therib82, hermetically seal the main fluid chamber55 (FIG. 2).
• Thebellows portion148 extends between the mountingportion140 andnozzle cover150, and comprises a plurality serpentine or inversely curledportions152 which function to provide resiliency in a direction generally parallel to acentral axis154 and sufficient spring-like force to either drive the piston or the nozzle away from the other and return the piston to the top of its stroke upon dispensing a predetermined dose of a medicament or other substance contained within thechamber55. Referring also toFIGS. 2 and 6, thenozzle cover150, when mounted, is dimensioned and configured to resiliently engage thenozzle58 andslide60, and includes theannular rib126 extending axially from adisc engagement portion156. Thedisc engagement portion156 is disposed between aslide engagement portion158 and a nozzlebody engagement portion160. Referring also toFIG. 6, the nozzlebody engagement portion160 is configured to engage the taperedouter surface102 of thenozzle58 to thereby form a normally-closed, one-way valve therebetween. As can be seen inFIG. 8, the cross-sectional thickness of thenozzle engagement portion160 gradually decreases in the axial direction from thedisc engagement portion156 toward the dispensingtip161. The gradually-decreasing cross-sectional thickness of thenozzle engagement portion160 facilitates the release of the medicament or other substance through the one-way valve formed by the elongated, annular interface between the relatively flexiblenozzle engagement portion160 of the cover and thetapered surface102 of the nozzle body, while simultaneously preventing air or other gases from passing through the valve in the opposite direction, in accordance with the teachings of the below-mentioned patents incorporated by reference herein.
• As shown inFIG. 6, theconical portion98 defines a tapered outer surface orvalve seat102. The interference fit between thenozzle cover150 and thevalve seat102 forms a normally-closed valve to hermetically seal the openings or slot116 until a dose of the substance contained in the dispenser is delivered. As shown, the portion of thenozzle cover150 that interfaces with thevalve seat102 is preferably tapered such that the thickness is greater near the base of the valve seat and gradually reduces to a lesser thickness near the end of the valve seat to facilitate opening of the valve and the flow of substance therethrough. In addition, the axial length of each of thevalve seat102,nozzle cover150 and annular valve opening formed therebetween is sufficiently long to always maintain an annular segment of the valve cover in contact with the valve seat when dispensing substance through valve opening. As can be seen, thenozzle cover150 defines an aperture therethrough, thevalve seat102 is received within the aperture to form the normally-closed annular valve opening at the interface between the valve seat and valve cover, and the diameter (or width) of the valve seat is greater than the diameter (or width) of the aperture in the cover to thereby form an interference fit and normally-closed valve opening therebetween. Preferably, the degree of interference between the valve cover aperture and valve seat decreases in the axial direction of the valve seat from the interior toward the exterior of the dispenser to facilitate the flow of substance therethrough.
• As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the one-way valve of the dispensers of the present invention may take any of numerous different configurations that are currently or later become known for performing the function of the valve described herein, including any of the one-way valve configurations disclosed in co-pending patent application Ser. Nos. 60/403,484, filed Aug. 13, 2002, 10/272,577, filed Oct. 16, 2002, and 10/640,500, filed Aug. 13, 2003, each of which is hereby expressly incorporated by reference as part of the present disclosure.
• In operation, as described above in connection withFIGS. 1 and 1A, movement of thevial52 in the axial direction causes thepiston56 to move from the position shown inFIG. 2 into the position shown inFIG. 3 (or vice versa), e.g., by actuating the trigger28 ofFIG. 1 or other actuator, which draws fluid into the variablevolume fluid chamber113 from themain fluid chamber55 via thecentral bore68 and laterally-extendingbore86 of the piston. Referring now also toFIGS. 6 and 8, as thepiston56 moves toward the nozzle58 (or vice versa), the fluid is injected through the slot116 (FIG. 6), along the flattened surface132, between thetapered surface102 and nozzlebody engagement portion160, and then outwardly of the nozzle tip. Further details of pump assemblies that may be used in the practice of the present invention are described in U.S. Pat. Nos. 5,944,702, 5,875,931 and 5,746,728, which are assigned to the same assignee as the present invention, and are hereby expressly incorporated by reference as part of the present disclosure.
• One advantage of the pump configuration of the illustrated embodiment, and as indicated by the arrow indicating the path of fluid flow inFIG. 6, the pumped fluid follows a fairly straight path extending in a direction parallel to theaxis154 from thevariable stroke volume113, over the tapered surfaces of theengagement portion106, through theslot116, and between the one-way valve formed by the interface of thenozzle engagement portion160 of the cover and the taperedouter surfaces132 and102 of the nozzle body. This relatively straight and smooth fluid flow path allows the pumped fluid to flow through the nozzle with relatively little head loss, thus allowing lesser force to dispense the fluid and otherwise facilitating precise control over the type of fluid flow to be emitted at the dispensing tip, such as control over drop size, flow velocity, and/or spray droplet size, spray pattern, etc.
• Yet another advantage of the illustrated pump configuration is that thebellows148 is sealed relative to the variable-stroke volume113 to thereby prevent any of the medicament or other substance contained within thechamber55 from collecting in the space between the bellows and the piston or slide. As can be seen, the o-ring or likeseal90 forms a fluid-tight seal between the piston and the slide, thus preventing any fluid from flowing therethrough and into the bellows. Similarly, fluid-tight seals are formed at the interfaces of thecover62,nozzle58 andslide60, including fluid-tight seals at the interfaces of theslide engagement portion158 of the cover and theslide60, and at the interface of theannular rib126 of the cover and at theannular groove122 of thenozzle58.
• Referring now toFIGS. 9 and 9A, thevial52 is preferably composed of a suitably rigid and moldable material, such as a rigid polymeric material, e.g., polycarbonate or polyvinylchloride. Preferably, this material is selected to be compatible with a wide variety of medicaments, such as that sold under the trademark Lexan of the General Electric Corporation of Pittsfield, Mass. Thevial52 is tubular in configuration and comprises anouter wall77 that defines themain fluid chamber55, the annular mountingflange78 discussed above in connection withFIGS. 2 and 4, and an annular connectingportion162 formed on an opposite end of the vial relative to the mountingflange78. Themain fluid chamber55 is dimensioned such that it is large enough to contain a predetermined quantity of a fluid to be dispensed, such as a medicament, along with the flexible bladder54 (FIG. 2) discussed in more detail below. The mountingflange78 includes anannular ridge164 for mounting thevial52 into sealing engagement with the nozzle cover62 (FIG. 2) and preventing movement of the cover during use of thedispenser10. As seen inFIGS. 2 and 3, the mountingportion146 of thecover62 is sandwiched between the base64 of thepiston56 and therigid vial52 to form a fluid-tight seal.
• As shown inFIG. 9A, the annular connectingportion162 comprises atapered end166 and aperipheral groove168 spaced inwardly therefrom on an increaseddiameter portion170. Anannular ridge172 is provided for engaging the flexible bladder54 (FIG. 2). As described further below, the increaseddiameter portion170 andannular ridge172 function to allow hermetic sealing of themain fluid chamber55 after assembly of thevial52. As also described further below, anannular groove174 is provided for retention of thevial52 during filling of themain fluid chamber55.
• Referring now toFIG. 10, theflexible bladder54 may be composed of any suitably flexible material, and preferably defines barrier properties to prevent the passage therethrough of vapor, moisture and gas. For ease of manufacture, the material preferably may be molded and is compatible with a wide variety of medicaments or other substances to be contained within thechamber55, and therefore in a preferred embodiment may be formed of a rubber or synthetic rubber. Alternatively, theflexible bladder54 may be composed of a thermo-elastic material, such as the styrene-butadiene elastomer sold under the trademark KRATON as discussed above in connection with thepump cover62. Similarly, materials sold under the trademarks VISKAFLEX owned by the AES Company, ALCRYN or HYTREL owned by the Dupont Company of Wilmington, D.E., and SARLINK owned by the DSM Company may be used instead. These materials are only exemplary, however. As may be recognized by those skilled in the pertinent art based on the teachings herein, the flexible bladder may be made of any of numerous other materials that are currently or later become known for performing the function of the flexible bladder as disclosed herein.
• In the preferred embodiments of the present invention, theflexible bladder54 is made of a resilient material as described above and is molded in the expanded condition. Accordingly, when collapsed in the manner described further below, the resilient bladder tends to force itself outwardly and, in turn, increase the pressure of the medicament or other fluid in themain fluid chamber55 in comparison to the pressure in the interior of the bladder. A significant advantage of this pressure differential is that it facilitates in preventing the ingress of air, other gases or vapors located within the interior chamber of the bladder through the bladder or otherwise into the main fluid chamber. As a result, the dispensers of the present invention are particularly well suited for containing multiple dose, non-preserved medicaments or other substances, and in maintaining such substances in a sterile, airless condition, throughout substantial periods of storage, shelf life and/or use of the dispensers. This advantageous feature also facilitates in preventing any changes in the ambient conditions of the dispenser from affecting the airless condition of themain fluid chamber55, and otherwise prevents the ingress of air, other gases or vapors into the main fluid chamber.
• Theflexible bladder54 preferably also provides a barrier to the passage of gas, such as air, through the flexible bladder, and thus may be composed of a single layer of material that has a substantially reduced permeability to air. In one embodiment of the present invention, thebladder54 is composed of a multi-layered material. For example, as illustrated inFIG. 10B, abladder wall175 may comprise a firstflexible layer177 of an elastomer that is relatively porous to air, and a barrier layer179, such as a metallized MYLAR, e.g., an aluminum and polyester composition, sold by the Dupont Corporation of Wilmington, Del., that is relatively impervious to air. The barrier layer179 may be disposed between a polyethyleneupper layer181 andlower layer183 to facilitate adhesion of the barrier layer to thebladder wall175 while maintaining flexibility. Alternatively, the barrier layer179 may be composed of polyvinylidene chloride sold under the mark SARAN owned by the Dow Chemical Company of Midland, Mich. It will be appreciated that the barrier layer179 is preferably dimensioned to cover as much of thebladder wall175 as permitted in order to reduce the passage of air therethrough without interfering with the various functions of the flexible bladder as more fully described below. The barrier layer179 is also preferably disposed on the interior of thebladder wall175. Optionally, the barrier material may be a butyl rubber-based material, such as that used for the manufacture of syringe stoppers, or used in the tire industry. As may be recognized by those skilled in the pertinent art based on the teachings herein, the flexible bladder and barrier materials disclosed herein are only exemplary, and any of numerous other materials that are currently known, or later become known for performing the functions disclosed herein, may be equally employed.
• Referring now again toFIG. 10, theflexible bladder54 is tubular in configuration and comprises aclosed end176 and anopen end178 that fluidly communicates with acavity180. Thebladder54 defines an external diameter dimensioned to fit within the vial52 (FIG. 2) when in the expanded condition as shown inFIG. 10. As shown inFIGS. 2 and 3, the outer surface of thebladder54 preferably defines a shape or morphology substantially the same as that of the interior surface of therigid vial52 so that upon expanding the flexible bladder, the flexible bladder conforms to and contacts the rigid vial throughout the interface of these two components to thereby eliminate any ullage or dead space between the components, and force all of the medicament or other substance within thechamber55 into thevariable stroke volume113 of thepump50 for dispensing therefrom. In addition, the outer diameter (or width) of the flexible bladder when fully expanded is preferably slightly greater than the inner diameter (or corresponding width) of the rigid vial, so that the expanded bladder may exert a resilient force against the vial to maintain at least a slight pressure differential between thechamber55 on one side of the bladder and the interior of the bladder and thereby prevent the ingress of air, other gases or vapors through the bladder and into the main fluid chamber, as described above.
• As shown inFIGS. 10 and 11, longitudinally extending stiffeners orrib portions182 are disposed along theinside surface184 and function to provide a supporting structure about which thebladder54 may collapse as will be described in more detail below in conjunction withFIG. 12. To achieve this, therib portions182 extend axially along theinterior surface184 and are approximately equally spaced about the circumference of the interior surface. It will be recognized that other configurations of therib portions182 and/or locations at which the rib portions may be employed are contemplated by the present invention. For example, therib portions182 also may extend along theinside surface183 of theclosed end176 of theflexible bladder54.
• As illustrated inFIGS. 10 and 10A, theflexible bladder54 includes a mountingportion186 that comprises anannular flange188 formed at the rear end of the bladder, an outerannular lobe190 spaced axially inwardly relative to theflange188, and an innerannular lobe192 spaced between the outerannular lobe190 and theflange188. As shown inFIG. 10A, theannular flange188 defines on its underside an annular, V-shapedindent194 for sealing engagement with theannular ridge172 of the vial52 (FIG. 9A). In addition, theannular flange188 is over-sized so that during initial assembly with thevial52, as will be discussed in more detail below, the peripheral surface of the annular flange may engage the correspondingannular groove168 of the vial52 (FIG. 9A).
• During storage and/or shelf life of thedispenser10, the material of theflexible bladder54 may flow or move in order to equalize the tensile and compressive forces that it is subject to. Creep, as used herein, refers to a change in property of the material wherein there is a loss in resilience and memory of the material. In particular, after undergoing creep the elastic material may permanently deform and lose at least some of its original elasticity. Accordingly, after assembly and during filling of thedispenser10, thecavity180 of theflexible bladder54 may be subject to low pressure which causes collapse and elastic deformation thereof which is maintained by the pressure of fluid filled in the main fluid chamber55 (FIG. 2). Thereafter, the filled dispenser may be maintained in storage and/or on a store or other shelf for at least two or more months prior to use, during which the material of the bladder may undergo creep causing at least some deformation thereof. To properly manage the movement of the material during creep of theflexible bladder54, and as shown best inFIG. 10A, the bladder is provided with the outerannular sealing lobe190 and the innerannular sealing lobe192 spaced axially between the outer sealing lobe and theflange188 so that, when creep resulting from compression of the elastomeric or rubber-like material occurs, the intra material pressure is balanced in between the twolobes190,192 and a persistent, fluid-tight seal is provided. This mechanical seal can then be maintained due at least in part to the material reservoir formed by theinner lobe192 in which creeping material in theouter lobe190 offsets that of the inner lobe.
• As shown inFIG. 10A, the outerannular lobe190 comprises a firstangular portion198 located on one side of thelobe192, and a secondangular portion200 disposed on the opposite side of the lobe. The firstangular portion198 defines a first acute angle “A” with respect to acenter axis202 that may be within the range of approximately 0° to approximately 30°, and more preferably within the range of approximately 0° to approximately 10°. The secondangular portion200 defines a second acute angle “B” relative to theaxis202 that may be within the range of approximately 0° to approximately 15°, and more preferably within the range of approximately 0° to approximately 5°. In order to ensure that during creeping of the material of theflexible bladder54 the material moves approximately in the directions of thearrow204 andarrow205, the first angle A is larger than the second angle B and the flexible bladder is axially fixed by the innerannular sealing lobe192 received within the correspondingannular groove22 of the rear plug (FIG. 14). As shown inFIGS. 2 and 3, when theflexible bladder54 is fully received within therigid vial52, the outerannular lobe190 is pressed against the smooth interior wall of the vial, the innerannular lobe192 is received within the correspondingannular groove22 of the rear plug (FIG. 14), and theannular flange188 is sandwiched between the rear plug and theannular ridge172 of the rigid vial. Thus, the innerannular sealing lobe192 functions as a material reservoir for the outerannular sealing lobe190, and as indicated by thearrows204 and205, the axially-offset lobes cause the material to flow generally from theouter lobe190 toward theinner lobe192, and from both lobes generally toward theannular flange188. As a result, the material flow is persistently directed toward theinner sealing lobe192 and/orannular flange188 to thereby maintain a fluid-tight seal between the flexible bladder, rigid vial and rear plug, regardless of the degree of creep of the bladder material. As can be seen, the shape and relative position of the outerannular lobe190 as described above facilitates in directing the forces within the bladder and thus the material in the directions of thearrows204 and205 to thereby maintain the fluid-tight seal throughout the storage, shelf-life and usage of thedispenser10.
• As shown inFIG. 11, theflexible bladder54 preferably also comprises at least onesurface discontinuity206 that facilitates and controls the collapse of the bladder from a tubular configuration to a predetermined collapsed configuration to thereby substantially eliminate the volume of thecavity180 defined by the interior of the bladder. In the illustrated embodiment, the flexible bladder comprises threesurface discontinuities206 located on theinterior surface184 of the bladder and approximately equally spaced relative to each other. As can be seen, thediscontinuities206 are each approximately equally spaced between adjacentelongated ribs182. Thediscontinuities206 are illustrated in the configuration of a crevice or crack terminating in a generally flat center portion (not numbered) in cross section as shown. As can be seen, thesurface discontinuities206 cause the bladder to collapse or fold onto itself about eachelongated rib182 to thereby form in the collapsed condition three folded sections or legs spaced about 120° relative to each other. As may be recognized by those skilled in the pertinent art based on the teachings herein, and illustrated by the additional embodiments below, any of numerous other structures or configurations may be equally employed to collapse the bladder into a predetermined shape, such as the predetermined collapsed shape formed by discontinuities and elongated ribs described above.
• Referring now toFIG. 12, a cross section of anouter wall208′ of aflexible bladder54′ is illustrated in schematic. Theflexible bladder54′ is capable of collapsing in the direction ofarrows210′ from an expanded position, shown in solid lines adjacent to theouter wall77 of the vial52 (FIG. 9) to a collapsed position shown in broken lines. Theflexible bladder54′ is functionally similar to theflexible bladder54 and thus like elements are labeled with like reference numerals followed by the prime (′) symbol. However, it will be recognized that some differences in structure exist between theflexible bladder54 and theflexible bladder54′. For example,discontinuities206′ are illustrated as being inverted with respect to thediscontinuities206 and generally cover the entire cross-sectional thickness (t′) of thewall208′. While thediscontinuities206′ are illustrated as generally arcuate in configuration, it will be appreciated that other configurations, such as that ofdiscontinuities206, which also perform the function described below may be employed instead. Also, it will be appreciated that therib portions182′ define mountingslots209′ for receiving therein correspondingly-shaped portions (not shown) of thevial52.
• It will be understood that both thediscontinuities206 and206′ function to allow for a reduction in length of the portions of thewall208′ necessary to collapse theflexible bladders54 and54′. While this function is being described in connection with the embodiment ofFIG. 12, this description is equally applicable to the embodiment ofFIG. 11. As shown inFIG. 12, thewall208′ comprises a plurality ofwall portions212′ extending between eachdiscontinuity206′ andadjacent rib portion182′, and as shown in solid lines eachwall portion212′ forms an arc when thebladder54′ is expanded. It will be recognized that during collapsing of thebladder54′ in the directions of thearrows210′, thewall portions212′ become approximately linear and form a chord as shown in the dashed and dotted lines, and then inversely arcuate as illustrated in the dashed lines. Accordingly, as illustrated, a length L₁of thediscontinuities206′ shown in solid lines shortens to a length L₂shown in dotted and dashed lines to thereby allow free movement of thearcs212′ in the direction of thearrows210′. Once theflexible bladder54′ has collapsed, the bladder may expand and thewall portions212′ may freely move in a direction opposite that of thearrows210′.
• As illustrated inFIGS. 13 and 14, the flexible bladder comprises arear plug214 configured to mate with theopen end178 of the flexible bladder54 (FIG. 2) and to seal theflexible bladder54 disposed between the rear plug and therigid vial52. Therear plug214 may be composed of any suitably strong, moldable and durable material, such as a polymeric material, e.g., polyethylene, and is preferably composed of Lexan™ or a like polycarbonate for its stress-resistant properties. Therear plug214 comprises anend wall216 and aside wall218 that, as seen best inFIG. 14A, preferably includes a taperedportion220 defining a gradually increasing diameter in the direction of the rear end of the plug, anannular groove222 spaced rearwardly of the taperedportion220, a steppedportion224, a plurality of outwardly-protruding protective tabs226 (or bumps for ease of manufacturing) angularly spaced relative to each other about the axis of the plug, and anaperture228 extending through the side wall for allowing fluid communication between theinterior chamber180 of the bladder and the ambient atmosphere. The taperedportion220, because of the increasing diameter thereof, provides for ease of assembly of theplug214 to the flexible bladder54 (FIG. 2) and defines an annular space230 (FIG. 2) located between the plug and the adjacent surface of the flexible bladder. As described above and shown inFIGS. 2 and 3, theannular groove222 is configured to receive the inner annular lobe192 (FIG. 10) and the steppedportion224 sandwiches theannular flange188 of theflexible bladder54 against theannular ridge172 of the rigid vial. As best seen inFIGS. 13 and 14, thesafety sealing tabs226 project upwardly and outwardly from the steppedportion224 and are angularly spaced relative to each other about the axis of the plug. The sealingtabs226 are provided for locking theplug214 to the vial52 (FIG. 2) and are configured to snap-fit within theannular groove168 of the vial (FIG. 9) upon being pressed against theannular flange188 of the bladder to thereby maintain an airtight seal. In addition, because the sealingtabs226 are tapered outwardly as shown typically inFIG. 14A, the tabs easily snap into theannular groove168 of the vial; however, the tabs cannot be moved out of the groove in the opposite direction and thereby form a tamper-proof seal. Theaperture228 provides for fluid communication between theannular space230, chamber180 (FIG. 2) and ambient atmosphere, and is illustrated as being generally rectangular in configuration. However, it will be understood that other configurations, such as circular or other shapes, may be employed, providing that a sufficient volume of air may pass therethrough to fill theinterior chamber180 of theflexible bladder54.
• Returning toFIGS. 10 and 10A, theflexible bladder54 also preferably comprises a two-way valve234 axially spaced below the sealinglobes190 and192 for controlling the flow of air between theinterior chamber180 of the bladder and ambient atmosphere. Thevalve234 comprises anannular operator235 projecting inwardly from the interior wall of the bladder and having a generally ridge-like configuration in cross section. As shown inFIGS. 2 and 3, the end portion of theannular operator235 engages theannular surface232 formed at the base of therear plug214, and is disposed between theannular space230 and theinterior chamber180 of the bladder. Theflexible bladder54 further defines a plurality ofsupport protuberances236 that are axially spaced adjacent to theannular operator235 and angularly spaced relative to each other about theaxis202. The end surface of eachprotuberance236 is spaced inwardly relative to the end of theannular operator235 to thereby allow theoperator235 to engage and seal the interface between the operator and rear plug, while simultaneously ensuring sufficient radial spacing between the rear plug and flexible bladder for allowing movement of theoperator235 in either direction. Thus, as can be seen, theoperator235 andannular wall232 of the rear plug form a two-way valve allowing fluid to flow therethrough when the differential pressure across the valve is sufficient to axially flex the operator. It will be understood that the rigidity of the operator is set to allow fluid to pass therethrough when the pressure differential exceeds a predetermined threshold pressure. Thus, a significant advantage of thevalve234 is that it maintains a relatively stable micro-atmosphere within theinner chamber180 of theflexible bladder54 and prevents a regular exchange of air, other gases or vapors between the micro-atmosphere within the bladder and the ambient atmosphere. For example, thevalve234 allows air to be drawn into thechamber180 upon dispensing the medicament or other substance from themain fluid chamber55 to thereby allow the bladder to expand and fill the space of the dispensed medicament. However, thevalve234 otherwise prevents air or vapors from flowing freely between the micro-atmosphere and the ambient atmosphere. Thus, the micro-atmosphere within thechamber180 may define different pressure and/or humidity levels in comparison to the ambient atmosphere. A significant advantage of this feature is that it insulates the micro-atmosphere from fluctuations in the pressure and/or humidity levels of the ambient atmosphere, thereby maintaining relatively stable pressure and humidity levels within the micro-atmosphere and thus preventing the ingress of air or vapors through the bladder wall and into the main fluid chamber.
• InFIGS. 15A-15C, thedispenser10 is illustrated in the full, half-full and empty conditions, respectively. InFIG. 15A, themain fluid chamber55 is filled with, e.g., a medicament (not shown) that thepump assembly50 may pump outwardly of thenozzle58. Accordingly, thebladder54 is illustrated in a collapsed state. InFIG. 15B, theflexible bladder54 is shown in an expanded condition whereby the bladder has expanded to displace the volume of medicament dispensed from themain fluid chamber55. To achieve this result, air has passed in the direction ofarrow240, through thevalve234 and into theinterior chamber180 of the flexible bladder. InFIG. 15C, thedispenser10 is illustrated in an empty condition. As can be seen, thebladder54 is fully expanded againstwall77 of the rigid vial and substantially conforms to the morphology of the rigid vial to thereby eliminate any ullage or dead space and force all medicament or other substances therein into thepump50.
• Referring now toFIGS. 16A-16C, initial assembly of thedispenser10 for purposes of sterilization, e.g., by irradiation of energy rays, is illustrated inFIG. 16A. In particular, therear plug214 is fitted to theflexible bladder54, and the plug and flexible bladder are partially inserted into thevial52. Turning now also toFIGS. 9A and 10, theflange188 of theflexible bladder54, when in the partially inserted position, is disposed within theannular groove168 of thevial52 to thereby form an air-tight, but not a tamper-proof seal between the bladder and vial. In this state, thedispenser10 may be sterilized and/or transported in a sealed condition prior to filling the dispenser with a medicament or other substance to be contained therein.
• The filling of thedispenser10 is illustrated schematically inFIG. 16B, wherein theflexible bladder54 and plug214 are separated from thevial52 so that themain fluid chamber55 may be accessed for filling. As can be seen, theannular flange188 of the bladder may be pulled rearwardly and removed from theannular groove168 of the vial to thereby open the vial and access themain fluid chamber55. Preferably, this operation may be carried out by transporting the sterilized dispensers through a sterile transfer port, and filling the dispensers within a sterile filling machine of a type disclosed, for example, in commonly-assigned U.S. Pat. Nos. 5,641,004 and 5,816,772, which are hereby expressly incorporated by reference as part of the present disclosure. During filling, a vacuum may be drawn on theinner chamber180 of the bladder to collapse the bladder, and the medicament or other substance to be contained therein may be introduced into themain fluid chamber55. In some embodiments, themain fluid chamber55 is overfilled, i.e., the amount of medicament supplied to the chamber is greater than the amount that the chamber can hold with the bladder and plug inserted. This helps eliminate the possibility of trapped air in the main fluid chamber upon insertion of thebladder54 and rear plug214 (i.e., the main fluid chamber will be filled solely with medicament or other substance).
• As shown inFIG. 16C, upon filling themain fluid chamber55 with the medicament or other substance to be contained therein, the flexible bladder and rear plug assembly are moved into the rigid vial such that theflexible flange188 of the bladder is moved into engagement with theannular ridge172, best seen inFIG. 9A, and the rear plug is pressed inwardly until the sealingtabs226 are snapped into place within theannular groove168 of the vial to thereby form the airtight and tamper-proof seal. Thedispenser10 may then be installed within theocular treatment apparatus8 described above or other suitable apparatus for dispensing medicaments or other fluids, such as nasal inhalers.
• In some embodiments, it is desirable to use a vacuum to “catch” any medicament or other substance that overflows from the vial during the insertion of the bladder and rear plug. This is particularly true where themain chamber55 was overfilled prior to installing the bladder and rear plug, in order to help prevent the possibility of trapped air in the main chamber after the bladder and rear plug are inserted. Otherwise, any excess medicament or other substance will spill out of the vial upon insertion of the bladder and rear plug.
• InFIGS. 17 through 20, another embodiment of the dispenser of the present invention is indicated generally by thereference numeral310. Thedispenser310 is substantially similar to thedispenser10 described above, and therefore like reference numerals preceded by the numeral “3”, or preceded by the numeral “4” instead of the numeral “1”, or preceded by the numeral “5” instead of the numeral “2”, respectively, are used to indicate like elements. The primary differences of thedispenser310 in comparison to thedispenser10 are that (i) therigid vial352 andpiston356 are formed as integral components; (ii) thenozzle358 and slide360 are formed as integral components; (iii) theflexible bladder354 defines a smooth cylindrical configuration without any discontinuities or ribs formed thereon; and (iv) therear plug514 includes a plurality of inwardly projectinglegs538 for controlling the collapse of the flexible bladder into a predetermined collapsed shape.
• As shown inFIGS. 21-23, therear plug514 defines a plurality of inwardly projecting, axially-elongatedlegs538 defining a framework within theinterior chamber480 of theflexible bladder354 for controlling the collapse of the bladder into a predetermined collapsed shape. As shown inFIG. 21, the illustrated embodiment of the present invention includes threelegs538 angularly spaced approximately 120° relative to each other about the axis of the rear plug. Each leg lies in a respective plane intersecting the axis of the rear plug and defines approximately planar side surfaces540 extending radially between the axis of the plug and the inner wall of the rigid vial. As shown inFIG. 19, theradial edge542 of each leg is radially spaced inwardly relative to the inner wall of the rigid vial to thereby allow movement of the flexible bladder between the radial edges of the legs and the vial. As also shown inFIGS. 19 and 20, thelegs538 extend axially into theinterior chamber480 of the flexible bladder a distance sufficient to allow the legs to control the collapse of the bladder into the predetermined collapsed condition. In the illustrated embodiment, eachleg538 extends along at least about one-half the axial extent of the bladder. As shown inFIG. 24, in the predetermined collapsed condition, theflexible bladder354 conformably engages the outer surfaces of thelegs538 to thereby allow the mainfluid chamber355 to be filled with a medicament or other substance. Then, as shown inFIG. 25, upon dispensing all of the medicament or other substance from the mainfluid chamber355, the resilient nature of theflexible bladder354 causes the bladder to expand outwardly away from thelegs538. As shown typically inFIGS. 19 and 20, when fully expanded, theflexible bladder354 conformably engages the inner wall of the rigid vial to thereby eliminate any ullage or dead space and allow all of the medicament or other substance contained with the mainfluid chamber355 to be dispensed therefrom.
• As described above, theflexible bladder538 is preferably made of a relatively low permeability elastomer, such as a vulcanized butyl rubber, or other rubbers. Such rubbers have demonstrated proven stability and/or compatibility with a wide variety of medicaments, such as pharmaceutical preparations and vaccines, and other substances, and therefore are currently preferred for such applications. In the currently preferred embodiment, theflexible bladder354 is molded in its expanded condition, and when collapsed, the resilient nature of the bladder tends to force the bladder outwardly toward its expanded condition. The resilient forces within the bladder apply a pressure against the fluid within the mainfluid chamber355, and therefore create a higher pressure in the mainfluid chamber355 in comparison to that of theinterior chamber480 of the bladder. As a result, the pressure differential prevents the ingress of air or other gases or vapors through either the flexible bladder or rigid vial, or otherwise into the main fluid chamber. Thus, the material and/or configuration of the bladder are preferably selected to maintain a pressure differential sufficient to prevent the ingress of air or other gases or vapors into the main fluid chamber under a variety of atmospheric conditions. As described above, the preferred rubber materials disclosed herein for constructing the flexible bladder are exemplary, and numerous other materials that are currently, or later become known for performing the function of the flexible bladder may be equally employed.
• As shown inFIGS. 26 and 27, the spacedprotuberances236 described above in connection with theflexible bladder54 ofFIG. 10A may be eliminated depending upon the material of construction and/or other structural features of theflexible bladder354. In addition, the outer annular lobe may take a shape different than that illustrated above in connection with the bladder ofFIG. 10A. As shown inFIG. 27, the outerannular lobe490 is defined by an annular raised or thickened portion, and atapered surface498 extending radially inwardly between the lobe or annular raisedportion490 and the outer peripheral surface of theflexible bladder354. As shown inFIGS. 19 and 20, the annular raisedportion490 is squeezed against the inner surface of therigid vial352 which, in combination with the axially offset, innerannular lobe492 being fixedly received within theannular groove522 of the rear end cap (FIG. 23), cause the material of the flexible bladder to creep and/or otherwise flow in the directions of thearrows504 and505 inFIG. 27 to thereby persistently maintain an airtight seal between the flexible bladder, rear plug and rigid vial. Thus, the end seal of the flexible bladder is both radially compressed at the axially offset lobes between the rear plug and rigid vial, and is axially compressed at the flange between the rear plug and rigid vial.
• As shown typically inFIG. 22, therear plug514 defines threeapertures528 approximately equally spaced relative to each other about the axis of the plug. In addition, rather than defining the sealingtabs226 described above in connection withFIG. 14, therear plug514 defines anannular lobe526 projecting outwardly from the peripheral surface of the rear plug and dimensioned to be snapped into theannular groove168 of the rigid vial (FIG. 30). Thedispenser310 may be sterilized, temporarily closed, re-opened, and filled in the same manner as described above in connection withFIGS. 16A through 16C.
• As shown inFIGS. 28 and 29, thenozzle358 and slide360 are formed integral with each other. One advantage of this construction over the separate nozzle and slide described above in connection with the previous embodiment, is that the integral construction is typically less costly to manufacture and assemble, and furthermore, reduces the number of seals between components and thereby enhances the overall reliability of the dispenser.
• As shown inFIGS. 30 and 31, thepiston356 andrigid vial352 are also formed integral with each other. As with the integral nozzle and slide described above, one advantage of this construction over the separate piston and slide described above in connection with the previous embodiment, is that the integral construction is typically less costly to manufacture and assemble, and furthermore, reduces the number of seals between components and thereby enhances the overall reliability of the dispenser. In one currently preferred embodiment of the present invention, theintegral nozzle358 and slide360 is made of a relatively soft material, and theintegral piston356 andvial352 is made of a relatively hard material. In the operation of thedispenser310, on the downward stroke of thepiston356, and upon reaching thecompression zone436 of the slide360 (FIG. 29), the relative hardness and geometry of the illustrated piston causes the piston to force thecompression zone436 of the slide outwardly, or otherwise sealingly engage the compression zone of the slide, and thereby form a fluid-tight seal between the piston and slide. As illustrated inFIG. 30, the tip of the guide wall394 defines a chamfer for facilitating sliding movement of the piston within the slide.
• Forming the integral nozzle and slide of a relatively soft and/or flexible material allows thecompression zone436 of the slide to flex outwardly in order to remove the part from a core pin upon molding the part, and thus enables the nozzle and slide to be integrally molded as a single part. Preferably, compressed air is injected between the core pin andinterior surface392 of the slide to facilitate removal of the part from the core pin (not shown).
• As shown inFIGS. 19 and 20, when theflexible bladder354 is at or near its fully-expanded condition, an annular gap “C” is formed between the bladder and vial. As can be seen, the width of the gap C gradually increases in the axial direction moving from therear end cap514 toward theclosed end476 of the bladder. As can be seen, the gap C starts about half-way down the axial extent of the bladder and reaches its maximum width at the curved portion of the bladder between the side wall andend wall476. The gap C may be created by forming the approximately cylindrical side wall of theflexible bladder354 with a sufficient draft to form the gap upon insertion of the bladder into the rigid vial. The purpose of the gradually-increasing gap C is to force all fluid within the mainfluid chamber355 in the direction toward thepump350 and prevent the formation of any pockets of fluid within the main fluid chamber that cannot be dispensed therefrom.
• As shown typically inFIGS. 19 and 20, other than the slight differences necessary to create the gap C, theflexible bladder354 defines approximately the same morphology as the interior surfaces of therigid vial352, thus enabling intimate and conforming engagement of the bladder with the rigid vial upon full expansion of the bladder. In addition, theflexible bladder354 preferably defines in its fully expanded condition an outer diameter (or width) at least equal to or greater than the inner diameter (or width) of thechamber355 of the rigid vial. These features, in combination with the resilient nature of the flexible bladder, prevent the ingress of gases or vapors into the mainfluid chamber355, and ensure usage of substantially all fluid contained within the chamber.
• As shown inFIG. 32, theflexible cover362 defines anannular mounting flange380 on one end thereof which is received within a correspondingannular groove374 formed on the integral piston and rigid vial (FIGS. 30 and 31) to fixedly secure the flexible cover thereto. In addition, the integral piston and rigid vial defines anannular flange381 adjacent to theannular groove374 which is received within a correspondingannular groove382 of the flexible cover (FIG. 32) to further secure the cover thereto.
• Turning toFIG. 33, another embodiment of the dispenser of the present invention is indicated generally by thereference numeral610. Thedispenser610 is substantially the same as thedispenser310 described above, and therefore like reference numerals preceded by the numeral “6” instead of the numeral “3”, the numeral “7” instead of the numeral “4”, or the numeral “8” instead of the numeral “5”, respectively, are used to indicate like elements. The primary difference of thedispenser610 in comparison to thedispenser310 is that thedispenser610 includes a resealable bladder to allow the bladder to be filled in a sterile filling machine of the type disclosed in co-pending U.S. patent application Ser. No. 09/781,846, filed Feb. 12, 2001, now U.S. Pat. No. 6,604,561, which is assigned to the same Assignee as the present invention, and is hereby expressly incorporated by reference as part of the present disclosure.
• As shown inFIG. 33, theflexible bladder654 includes on its closed end776 aresealable portion844 overlying theclosed end776. In the illustrated embodiment, theflexible bladder354 is formed of a first material compatible with the predetermined medicament or other substance to be contained within the mainfluid chamber655, and defines on its external side a medicament-exposed surface intended to be exposed or otherwise placed in contact with the predetermined medicament or other substance contained within the main fluid chamber. Theresealable portion844 is penetrable by a needle or like filling member for introducing the predetermined medicament or other substance through the flexible bladder and into the main fluid chamber. The penetrable region of the flexible bladder is formed of a vulcanized rubber, and therefore is substantially infusible in response to the application of thermal energy thereto. The penetrable region of theresealable portion844, on the other hand, is fusible in response to the application of thermal energy thereto, thus allowing the penetrable region of the resealable portion to be hermetically sealed upon removing the needle or like filling member therefrom. In the illustrated embodiment, theresealable portion844 is insert molded onto the rubber bladder during which the thermoplastic resealable layer bonds itself to the underlying rubber layer. If necessary, a mechanical fastener of a type known to those skilled in the pertinent art may be used to facilitate attachment of the resealable portion to the end wall of the flexible bladder.
• Theresealable member844 is preferably made of a resilient polymeric material, such as a blend of the polymeric material sold by GLS under the registered trademark KRATON® and a low-density polyethylene, such as the polyethylene sold by Dow Chemical Co. under the trademarks ENGAGE™ or EXACT™. An important feature of theresealable member844 is that it be resealable to form a gas-tight seal after inserting a needle, syringe or like injection member through the resealable member. Preferably, the resealable member can be sealed by heating the area punctured by the needle in a manner known to those skilled in the pertinent art and described in the above-mentioned co-pending patent application. One advantage of the blended polymer described above is that it is known to minimize the degree to which the medicament or other substance can be absorbed into the polymer in comparison to KRATON® itself.
• As shown inFIG. 33, therear plug514 defines a fillingaperture846 formed therethrough and overlying theresealable member844. As shown in broken lines inFIG. 33, a double lumen needle or likeinjection member848 may be reciprocally moved through the fillingaperture846 to, in turn, pierce both theresealable member844 and underlyingclosed end776 of the flexible bladder. Theinjection member848 is coupled in fluid communication with a source (not shown) of medicament or other substance to be contained within the mainfluid chamber655 and is actuated to fill the chamber with the medicament or other substance. Upon filling the chamber, theflexible bladder654 is collapsed into its predetermined collapsed condition, as shown above, and the needle is withdrawn. If necessary, a vacuum may be drawn on theinterior chamber780 of the flexible bladder during filling to facilitate collapse of the bladder. Upon withdrawing the needle, a laser or other energy source (not shown) transmits a beam of laser radiation onto the penetrated region of the resealable member to seal the needle hole in the manner described in the above-mentioned co-pending patent application and thereby maintain the medicament or other substance contained therein in a sterile, hermetically sealed condition. The fillingaperture846 may be sealed with a cap850 (shown in broken lines) to maintain theinterior chamber780 of the flexible bladder in a sealed condition.
• In certain embodiments of the present invention, at least a portion of theresealable portion844 is formed of a thermoplastic material defining a needle penetration region that is pierceable with a needle to form a needle aperture therethrough, and is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto. In an alternative embodiment of the present invention, the entire body of theportion844 is formed of the thermoplastic material. In another embodiment of the invention as described above, an overlying portion of the resealable portion if formed of the fusible thermoplastic material, and an underlying portion of the resealable portion is formed of an infusible material, such as vulcanized rubber. Preferably, each thermoplastic portion or body defines (i) a predetermined wall thickness in an axial direction thereof, (ii) a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation at the predetermined wavelength and power to hermetically seal the needle aperture formed in the needle penetration region thereof in a predetermined time period and substantially without burning the needle penetration region (i.e., without creating an irreversible change in molecular structure or chemical properties of the material). In one embodiment, the predetermined time period is approximately 2 seconds, is preferably less than or equal to about 1.5 seconds, and most preferably is less than or equal to about 1 second. Also in this embodiment, the predetermined wavelength of the laser radiation is about 980 nm, and the predetermined power of each laser is preferably less than about 30 Watts, and most preferably less than or equal to about 10 Watts, or within the range of about 8 to about 10 Watts. Also in this embodiment, the predetermined color of the material is gray, and the predetermined opacity is defined by a dark gray colorant added to the resealable portion material in an amount within the range of about 0.3% to about 0.6% by weight.
• In addition, the thermoplastic material may be a blend of a first material that is preferably a styrene block copolymer, such as the materials sold under either the trademarks KRATON or DYNAFLEX, and a second material that is preferably an olefin, such as the materials sold under either the trademarks ENGAGE or EXACT. In one embodiment, the first and second materials are blended within the range of about 50:50 by weight to about 95:5 by weight (i.e., first material:second material). In one such exemplary embodiment, the blend of first and second materials is about 50:50 by weight. The benefits of such blends over the first material by itself are improved water or vapor barrier properties, and thus improved product shelf life; improved heat sealability; a reduced coefficient of friction; improved moldability or mold flow rates; and a reduction in hystereses losses. As may be recognized by those skilled in the pertinent art based on the teachings herein, these numbers and materials are only exemplary, however, and may be changed if desired or otherwise required in a particular system.
• FIGS. 34A-34C show anocular treatment apparatus908 according to another aspect of the present invention. As will be apparent in view of the description hereinafter, thetreatment apparatus908 is similar in many respects to the treatment apparatus8 (FIG. 1B).
• Referring toFIG. 34A, thetreatment apparatus908 includes ahousing912, aneye cover916 and atrigger918. Thehousing912 has afirst end919 and asecond end920. Theeye cover916 haswings923A,923B, which are pivotably connected to thefirst end919 of thehousing912. Thetrigger918, which is elongated and hasfinger grooves928, is pivotably connected to thesecond end920 of thehousing912. Thehousing912 generally defines an interior cavity (details of the inner cavity are shown inFIG. 37).
• Theapparatus908 further includes aneyelid depressor936, which has two spaced apart fingers937 (FIG. 34C) pivotably connected to thefirst end919 of the housing912 (i.e., the same end of the housing to which theeye cover916 is connected).
• Referring now toFIGS. 34B,34C, thehousing912 has twoportions939,941. The first portion939 (hereafter the “main portion”939) of the housing is generally U-shaped to define three side walls: afirst side wall943, asecond side wall945, and athird side wall947. The second portion941 (hereafter the “cover portion”941) is generally L-shaped to define afourth side wall949 and a fifth side wall951 (the fifth side wall being referred to herein as a bottom wall). One end of thecover portion941 is pivotably mounted to an upper region of themain portion939, as will be further described hereinafter. The other end of thecover portion941 hasprongs953 adapted to engage themain portion939. The engagement locks themain portion939 to thecover portion941 to provide a “closed state” (as shown) to thereby conceal the inside of thehousing912. Forcing theprongs953 toward one another causes theprongs953 to disengage from themain portion939, which frees one or both of the first and coverportions939,941 to pivot (relative to the other) to provide an “open state” and thereby expose the interior cavity generally defined by the housing912 (seeFIGS. 35A-35B,37).
• The pronged end of thecover portion941 extends into the region between the spaced apart fingers937 (FIG. 34C) of theeyelid depressor936. The spacing between thefingers937 is sufficient to ensure that theeyelid depressor936 and thecover portion941 are each able to pivot without interference from the other.
• FIGS. 35A-35B show thetreatment apparatus908 with thehousing912 in the open state, whereby acartridge957 in accordance with one embodiment of one aspect of the present invention can be seen. Thecartridge957 is used for storing and delivering medicament (or other substance).FIG. 36 is an enlarged perspective view of a portion of thetreatment apparatus908, showing further details of thecartridge957 and thecover portion941 of thehousing912.
• FIG. 37 is a partially exploded view, in perspective, of theocular treatment apparatus908, showing still further details of thecartridge957 and thecover portion941 of thehousing912.
• Referring toFIGS. 36,37, thecartridge957 includes acasing959, anozzle1058, and anactuator963. Thecasing959 can be viewed as having ananterior region965, amid region967, and a posterior region969 (FIG. 36). Theanterior region965 has a truncated conical-like shape. The mid andposterior regions967,969 are approximately cylindrical in shape except for two flattened (i.e., substantially planar)side walls971. Note that one of the flattened side walls is shown. The other flattened side wall is on the opposite side of thecartridge957. Providing flattened side walls narrows thewidth973 of thecartridge957 to enable the cartridge to fit within the interior cavity of the housing. The diameter of theposterior region969 is slightly greater than the diameter of themid region967. Theanterior region965 of the casing has awall975 with an aperture that receives a tip of the nozzle1068 and is in fluid communication with a fluid path out of the nozzle1068. In addition,projections977 extend radially from the anterior region of thecasing959. As will be further described hereinafter, theprojections977 are adapted to engage features on thecover portion941 of thehousing912, or to engage an eyelid depressor when used without thehousing912.
• In this embodiment, the casing comprises two halves, each of which is integrally formed. The two halves are ultimately joined together during fabrication of the cartridge.
• Theactuator963 comprises alever979, one end of which is pivotably connected to theanterior region965 of thecasing957 via ahinge981. The other end of thelever979 extends into an opening in theposterior region969 of thecasing957. In this embodiment, thelever979 is formed so as to have a radius “r”.
• Thecartridge957 is adapted to be inserted into thecover portion941 prior to using thetreatment apparatus908. If the cartridge becomes empty of medicament, thecartridge957 may be removed from thecover portion941 and replaced by another cartridge. In this embodiment, the cartridge is a self contained. Moreover, the cartridge is a substantially sealed unit, meaning that there are substantially no openings in the outside surface of the cartridge (other than the medicament flow path provided through the one way valve of the nozzle) that do not have a seal.
• To that effect, thecover portion941 haswalls983,985, andabutments987,989 that define a longitudinally extending seat to receive thecartridge957.Longitudinal ribs991 andtransverse ribs993 disposed on the inside of thecover portion941 further define the seat for thecartridge957 and cooperate with the walls,983,985, andabutments987,989, to properly position thecartridge957. The walls limit lateral movement of thecartridge957. Theabutments987,989 limit axial movement. In addition, each of the walls has anopening995 that cooperates with arespective projection977 on thecartridge957 so as to releasably retain thecartridge957 to thecover portion941 and further position thecartridge957 relative to thecover portion941 and thehousing912. The width of thecover portion941 is small enough to fit between the first andthird side walls943,947 of themain portion939 of thehousing912. Theabutment989 has aslot997 in flow communication with a flow path out of the nozzle1068.
• FIG. 38 is a partially broken away, side elevational view of one embodiment of the cartridge ofFIG. 357. In this embodiment, thecartridge957 includes apump assembly1050, arigid vial1052, aflexible bladder1054, apiston1056, anozzle1058, aslide1060, apump cover1062, anozzle cover1150, acavity1180, arear plug1214, and a valve1234, which are similar to thepump assembly350,rigid vial352,flexible bladder354,piston356,nozzle358,slide360,pump cover362,nozzle cover450,cavity480,rear plug514, andvalve534 described above with respect toFIGS. 17-20.
• Hereafter reference numerals preceded by the numerals “10” instead of the numeral “3” indicate similar elements. Similarly, reference numerals preceded by the numerals “11” instead of the numeral “4” indicate similar elements, and reference numerals preceded by the numerals “12” instead of the numeral “5” indicate similar elements. For example, therear plug1214 includes a plurality of inwardly projectinglegs1238 for controlling the collapse of the flexible bladder into a predetermined collapsed shape. Therigid vial1052 includes aperipheral groove1168 and has an annular ridge1172 for engaging theflexible bladder1054.
• There are however, three main differences to note. First, therigid vial352 has an increased diameter portion and an annular ridge (see increaseddiameter portion170 and annular ridge172 (FIG.9A)); however, in this embodiment, thevial1052 has only of a portion of an increased diameter portion1300 (FIGS. 39A,39B) and only a portion of an annular ridge1301 (FIGS. 39A,39B). This is because thevial1052 has flattened side walls1302 (FIGS. 39A,39B), which narrow the width of the vial so as to enable thevial1052 to fit within the interior cavity defined by thecasing959. As stated above, thecasing959 has flattened side walls971 (FIGS. 35-37) in order to fit within the interior cavity defined by thehousing912. Although not shown, the flattened side walls1302 (FIGS. 39A,39B) of thevial1052 are circumferentially aligned with and/or abut the flattened side walls971 (FIGS. 35-37) of thecasing959. Second, theslide1060 has aneck1303 that is approximately fifty percent shorter in length than the neck of the slide360 (see neck136 (FIG. 7)). This is so that the treatment apparatus will dispense approximately one half the dosage dispensed by the apparatus ofFIGS. 17-20. Third, the length of thepiston1056 is shorter than the length of thepiston356 order to accommodate the shorter length of the neck on theslide1060.
• It should be recognized that the dosage can be precisely controlled by controlling the volume defined by theneck1303. This is because, referring also now toFIGS. 4,7, once the annular wall94 (FIG. 4) of the piston56 (FIG. 4) reaches theneck1303 of theslide1060, theannular wall94 forms a seal that prevents medicament from backflowing into themain chamber55, and consequently, the amount of medicament trapped in theneck1303 of theslide1060 defines the amount of medicament to be expelled from the nozzle. Thus, for example, in some embodiments, the dosage amount is precisely ten micro liters (ul). However, as may recognized by those of ordinary skill in the pertinent art based on the teachings herein, the dosage volume may be precisely controlled or set to virtually any dosage volume that may be required for a particular application, or otherwise desired, including without limitation the following other dosage volumes: 15, 20, 25, 30, 35 or 40 microliters. Accordingly, a significant advantage of the currently preferred embodiments of the present invention is that the dosage volume can be precisely controlled, for example, to maximize the pharmacological benefits of a particular medicament, or to set the dosage volume to be substantially equal to (or to otherwise correspond to) the volume that can be received and retained within an ocular cul-de-sac.
• Thecartridge957 further includes aspring1304. Thespring1304 is disposed between the external surface of the posterior wall of therear plug1214 and the internal surface of the posterior wall of thecasing959. Aguide1306 on the rear plug andlongitudinal ribs1308 on thecasing959 retain the spring in a desired position. As will be described hereinafter, thespring1304 provides a force that helps overcome friction and propel the medicament dosage out of thecartridge957 and into the eye.
• As stated above, one end of thelever979 is pivotably connected to thecasing959 via thehinge981. The other end of thelever979 extends into theopening982 in thecasing959. The casing has a pair ofsurfaces1310,1312 that seal against the end of the lever extending into thecasing959. The radially inner one of thesesurfaces1310 seal against a radiallyinner surface1314 of thelever979. The radially outer one of thesesurfaces1312 seals against a radiallyouter surface1316 of thelever979.
• In the operation of the cartridge, a radially inward force is applied to thelever979. This forces a portion1318 of thelever979 into contact with thecasing959, which causes thelever979 to straighten, and thereby causes the end of the lever to move in a direction toward the posterior end of the cartridge and engage the portion of theannular ridge1301 of thevial1052. The lever continues to move toward the posterior end of the cartridge, which drives thepiston1056 in the same direction to thereby prime the pump (as described in detail above) and compress thespring1304. With increasing radial force applied to thelever979, the free end of thelever979 eventually disengages from the portion of theannular ridge1301 and thereby releases theintegral vial1052 andpiston1056 from the force of thelever979. As a result, and due to the resiliency or spring-like nature of the pump assembly1050 (as described in detail above) as well as the spring force of thecompressed spring1304, theintegral piston1056 andvial1052 move in a direction toward the anterior end of thecartridge957 and, in turn, force a predetermined dosage of medicament (or other substance) from thenozzle1058.
• FIGS. 40A-40B are partially broken away views of thetreatment apparatus908.
• FIG. 40C is a cross-sectional view of the ocular treatment apparatus ofFIG. 34A. Referring toFIG. 40C, thetrigger918 has oneend1330 pivotably connected to thehousing912 via apin1332. Theother end1334 of thetrigger918 is connected to anarm1336 with acurved end1338, which connects to an end of theeyelid depressor936, for pivotably moving theeyelid depressor936 upon actuating thetrigger918. Thetrigger918 further includes asurface1339 adapted to transmit an applied force to thelever979 of thecartridge957.
• In use, theeye cover916 of thetreatment apparatus908 is placed adjacent to the tissue surrounding the eye with theeyelid depressor936 engaging the tissue adjacent to the ocular cul-de-sac. Upon squeezing thetrigger918, theeyelid depressor936 rotates in the direction of thearrow1340, and in turn moves the tissue adjacent to the eye to expose the ocular cul-de-sac. Rotation of theeyelid depressor936 is caused by thearm1336 which thereby uncovers thenozzle1058. Simultaneously, thesurface1339 of thetrigger918 applies force to thelever979 of thecartridge957, which causes the cartridge to deliver a predetermined dosage of medicament (or other substance) from thenozzle1058, as described above.
• In some embodiments, thewings923A,923B of theeye cover916 are sufficiently pivotable so as to enable thewings923A,923B to cover at least a portion of thenozzle1058 when theapparatus908 is not in use.
• It should be recognized that, in this embodiment, the pivot for thetrigger918 and the pivot for thelever979 are on opposite sides of the apparatus. That is, the pivot for thetrigger918 is located generally in the posterior region of theapparatus908, the pivot for thelever979 is located generally in the anterior portion of theapparatus908. In some embodiments, the pivot for thetrigger918 and the pivot for thelever979 are approximately at opposite ends of the apparatus (e.g., the pivot for thetrigger918 is disposed approximately at one end, the pivot for thelever979 is located approximately at the other end). Note that in this embodiment, thetrigger918 and the lever each pivot in about the same direction, e.g., downward. Of course, other embodiments may employ other types of actuators and/or arrangements.
• FIG. 41A is a side elevational view, partly in section, showing another embodiment of arigid vial1452, abladder1454, and arear plug1614, shown in a filled and un-capped condition.FIG. 41B is a side elevational view, partly in section, showing the rigid vial, and bladder ofFIG. 41A in a capped condition. In this embodiment of therigid vial1452,bladder1454, andrear plug1614, there is no need for vacuum capping. Therigid vial1452,bladder1454, andrear plug1614 are similar to therigid vial1052,flexible bladder1054, andrear plug1214 described above with respect toFIG. 38. Hereafter reference numerals preceded by the numerals “14” instead of the numerals “10” indicate similar elements. Similarly, reference numerals preceded by the numerals “15” instead of the numerals “11” indicate similar elements, reference numerals preceded by the numerals “16” instead of the numerals “12” indicate similar elements, and reference numerals preceded by the numerals “17” instead of the numerals “13” indicate similar elements.
• Referring toFIG. 41B, therigid vial1052 includes aperipheral groove1568, an increaseddiameter portion1700, anannular ridge portion1701, amain fluid chamber1855, and anannular ridge1872 at an anterior portion of the increaseddiameter portion1700. Themain fluid chamber1855 is similar to the main fluid chamber55 (FIG. 9). Therear plug1614 has inwardly projectinglegs1638, anannular rib1800, and anannular surface1832. Theprojection legs1638 are similar to legs1238 (FIG. 38) for controlling the collapse of thebladder1454 into a predetermined collapsed shape. Theannular rib1800 forces thebladder1454 into sealing contact against an anterior portion of the increaseddiameter portion1700 of thevial1452, to thereby seal themain fluid chamber1855. Theannular surface1832, which is similar to the annular surface532 (FIG. 19), forces aposterior portion1900 of thebladder1454 into sealing contact with therigid vial1452, to thereby define, in cooperation with thebladder1454 and the increaseddiameter portion1700 of therigid vial1452, anannular chamber1834. As described below, the presence of theannular chamber1834 helps avoid spillage when capping the rigid vial.
• Referring toFIG. 41A, one method for filling themain fluid chamber1855 without vacuum capping is as follows. Themain chamber1855 of therigid vial1452 is supplied with a medicament (or other substance) to be contained therein. The chamber is preferably overfilled, i.e., the amount of medicament supplied to thechamber1855 is preferably greater than the amount that thechamber1855 can hold with the bladder and plug inserted. This helps ensure that themain fluid chamber1855 will be filled solely with medicament or other substance, upon insertion of thebladder1454 and rear plug1614 (i.e., no trapped air in the main fluid chamber1855).
• Referring now toFIG. 41B, theflexible bladder1454 andrear plug1614 assembly are moved into therigid vial1452 such that thebladder1454 engages theannular ridge1872 and therear plug1614 is pressed inwardly until theannular surface1872 snaps into place within theannular groove1568 of the vial to thereby force theposterior portion1900 of thebladder1454 into sealing contact with therigid vial1452 and form an airtight seal. By this process, the excess medicament or other substance is pushed out of themain chamber1855 but does not spill because it is captured by the anannular chamber1834. Consequently, there is no need to use a vacuum to capture the excess medicament. Of course, themain chamber1855 should not be filled to the extent that excess medicament or other substance will exceed (i.e., overflow) theannular chamber1834.
• Although thecartridge957 is shown used with a treatment apparatus having a number of features, e.g.,housing912,eye cover916,trigger918,eyelid depressor936, the cartridge can also be used with treatment apparatus having only a portion of these features. For example, in some embodiments, thecartridge957 is used in association with a treatment apparatus without a cover portion to hide the cartridge. Thus, even when mounted in the housing, the cartridge may be in plain sight at all times. In some other embodiments, for example, the cartridge may be used with a treatment apparatus that does not have aneye cover916, atrigger918, aneyelid depressor936. Of course, some treatment apparatus may have more features than that of thetreatment apparatus908.
• Moreover, although thecartridge957 is shown used within thetreatment apparatus908, it should be recognized that thecartridge957 could be used by itself, i.e., without the rest of theapparatus908. For example, the user could depress the lever of the cartridge with his or her hand. Furthermore, if desired, an eyelid depressor and/or other feature(s) may be combined with thecartridge957 in order to further assist the user in dispensing medicament. The eyelid depressor need not be trigger actuated as with theeyelid depressor936. An example of acartridge957 with one embodiment of an eyelid depressor1952 is shown inFIG. 46. Acartridge957 with another embodiment of an eyelid depressor1954 is shown inFIG. 48. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the eyelid depressors may take any of numerous different shapes and configurations that are currently known, or later become known for performing the functions of any of the various eyelid depressors as indicated herein.
• Furthermore, it should be understood that thecartridge957 is not limited to the specific embodiments of thecartridge957 shown above. For example, in some embodiments, the cartridge may not employ an integral pump and vial. Moreover, some embodiments may employ a different shape casing, a different actuator, and/or a different storage and/or delivery system.
• In addition, it should be understood that the dispensers and cartridges disclosed herein are not limited to eye treatment or even medical applications.
• FIGS. 42-45 show anocular treatment apparatus2008 according to another aspect of the present invention. Thetreatment apparatus2008 is similar to the treatment apparatus908 (FIGS. 34-40). Except where otherwise noted, reference numerals preceded by the numerals “20” instead of the numeral “9” indicate similar elements, reference numerals preceded by the numerals “21” instead of the numerals “10” indicate similar elements, and reference numerals preceded by the numerals “23” instead of the numerals “12” indicate similar elements, except where otherwise noted.
• For example, thetreatment apparatus2008 includes a housing2012, aneye cover2016, atrigger2018, and aneyelid depressor2036, which are similar to thehousing912,eye cover916,trigger918, andeyelid depressor936 of the treatment apparatus908 (FIGS. 34-40).
• The primary differences between thetreatment apparatus2008 and the treatment apparatus9008 relate to differences between thecartridge2057 and the cartridge957 (FIGS. 35-40). In particular, (i) thecartridge2057 has anactuator2063 that includes two living hinges instead of thecurved lever957, (ii) thecartridge2057 is open, instead of substantially sealed, so as to permit access to the components within thecartridge2057, (iii) thecartridge2057 does not employ a spring disposed between therear plug2314 and thecasing2059, (iv) thecartridge2057 does not have flattened portions corresponding to those of the cartridge957 (see flattened portions971 (FIG.37)), and (v) thenozzle2158 extends completely through thecasing2059.
• Although the lever and casing are shown above as being separate pieces, this is not required. For example, in some embodiments, the lever and casing are formed into a single integral component.
• FIGS. 47A-47D are views of another embodiment of a fluid storage anddelivery system2600 that may be used in the cartridge. This embodiment includes apump assembly2650, arigid vial2652, aflexible bladder2654, apiston2656, anozzle2658, aslide2660, apump cover2662, anozzle cover2750, acavity2780, arear plug2814, and a valve2834 (seeFIG. 47D).
• It should be recognized that although thecartridge957 is a substantially sealed unit, the present invention is not limited to cartridges that are substantially sealed units. For example, some embodiments may employ a cartridge that is self contained (or at least substantially self contained) but not substantially sealed. Other embodiments may employ a cartridge that is not even self contained.
• Although thesecond portion941 of thehousing912 hasprongs953 adapted to engage thefirst portion939 to releasably lock thefirst portion939 to thesecond portion941, this is not meant to preclude the use of other types of engaging structures to lock the first portion to the second portion.
• As stated above, the cartridge could be used by itself, i.e., without the rest of theapparatus908. In addition, the cartridges and/or dispensers disclosed herein are not limited to eye treatment or even medical applications.
• FIG. 49 is a partially broken away, perspective view of anocular treatment apparatus3008 according to another aspect of the present invention. Thetreatment apparatus3008 is similar to the treatment apparatus908 (FIGS. 34-40). Except where otherwise noted, reference numerals preceded by the numerals “30” instead of the numeral “9” indicate similar elements, reference numerals preceded by the numerals “31” instead of the numerals “10” indicate similar elements, reference numerals preceded by the numerals “32” instead of the numerals “11” indicate similar elements, reference numerals preceded by the numerals “33” instead of the numerals “12” indicate similar elements and reference numerals preceded by the numerals “34” instead of the numerals “13” indicate similar elements, except where otherwise noted.
• For example, thetreatment apparatus3008 includes ahousing3012, aneye cover3016, atrigger3018, and aneyelid depressor3036, which are similar to thehousing912,eye cover916,trigger918, andeyelid depressor936 of the treatment apparatus908 (FIGS. 34-40). Thehousing3012 includes first andsecond portions3039,3041, which are similar to first andsecond portions939,941.
• Thetreatment apparatus3008 further includes acartridge3057 that includes acasing3059, anactuator3063, apump assembly3150, arigid vial3152, aflexible bladder3154, apiston3156, anozzle3158, aslide3160, apump cover3162, acavity3280 and arear plug3314, which are similar to the apump assembly1050, arigid vial1052, aflexible bladder1054, apiston1056, anozzle1058, aslide1060, apump cover1062, anozzle cover1150, acavity1180 and arear plug1214, described above with respect toFIGS. 34-40.
• The primary differences between thetreatment apparatus3008 and thetreatment apparatus908 relate to differences between thecartridge3057 and the cartridge957 (FIGS. 35-40), differences between thetrigger3018 and thetrigger918, and differences between thehousing3012 and thehousing912. In particular, (i) thecartridge3057 has anactuator3063 which differs from theactuator963 in that theactuator3063 includes alever3079A and anarm3079B pivotally connected thereto (e.g., at or via anelbow3079C) in place of thelever979 employed by theactuator963, (ii) thecartridge3057 has a spring3404 (disposed between therear plug3314 and the casing3059), which unlike thespring1304 of thecartridge957, is joined to, integrally formed with, and/or extends from, theactuator3063 of thecartridge3057. As will be described hereinafter, thespring3404 provides a force that helps overcome friction and propel the medicament dosage out of thecartridge3057 and into the eye. Thetrigger3018, which is elongated and hasfinger grooves3028, includes (i) aseat3700 for thelever3079A, theseat3700 having a surface shaped to be complementary to the surface of thelever3079A, and (ii) an end3430 (pivotably connected to the housing3012), which is slotted so as to be able to slide axially onto the pin3432. Lastly, unlike thehousing912, thehousing3012 does not have a seat for said end3430 of saidtrigger3018.
• FIGS. 50A-50D are sequential side elevational views, partly in section, showing the operation of the ocular treatment apparatus ofFIG. 49 as progressively greater force is applied to the trigger.FIGS. 50E-50H are sequential side elevational views, partly in section, showing the operation of the ocular treatment apparatus ofFIG. 49 after the trigger is fully actuated and the trigger progressively returns to its initial state.
• Referring now toFIGS. 50A-50D, upon squeezing thetrigger3018, theeyelid depressor3036 rotates and in turn moves the tissue adjacent to the eye to expose the ocular cul-de-sac. Rotation of theeyelid depressor3036 is caused by thearm3436 which thereby uncovers thenozzle3158. Simultaneously, thetrigger3018 applies radially inward force to the lever3079 of thecartridge3057. This forces thelever3079A toward the housing3059 (note that in doing so thelever3079A slides along theseat3700 in the trigger3018) and forces theelbow3079C to begin to straighten, thereby causing the end of thearm3079B to move in a direction toward the posterior end of the cartridge and engage the portion of theannular ridge3401 of thevial3152. In some embodiments, the movement of the arm causes thespring3404 to compress. As additional radially inward force is applied, theelbow3079C further straightens and thearm3079B continues to move in the posterior direction, thereby driving thepiston3156 in the same direction so as to prime the pump (as described in detail above) and compress (or further compress) thespring3404.
• Referring now toFIGS. 50E-50H, with further radial force applied to thelever3079A, thearm3079B eventually disengages from the portion of theannular ridge3401 and thereby releases thevial3152 andpiston3156 from the force applied by thearm3079B. As a result, and due to the resiliency or spring-like nature of thepump assembly3150 as well as the spring force of thecompressed spring3404, thepiston3156 andvial3152 move in a direction toward the anterior end of thecartridge3057 and, in turn, force a predetermined dosage of medicament (or other substance) from thenozzle3158.
• FIG. 51 is a perspective view of the ocular treatment apparatus ofFIG. 49, with the housing in an open state.
• FIG. 52 is a partially exploded view, in perspective, of the ocular treatment apparatus ofFIG. 49.
• FIG. 53 is a partially exploded side elevational view, of the ocular treatment apparatus ofFIG. 49.
• Although thecartridge3057 is shown used with a treatment apparatus having a number of features, e.g.,housing3012,eye cover3016,trigger3018,eyelid depressor3036, the cartridge can also be used with treatment apparatus having only a portion of these features. For example, in some embodiments, thecartridge3057 is used in association with a treatment apparatus without a cover portion to hide the cartridge. Thus, even when mounted in the housing, the cartridge may be in plain sight at all times. In some other embodiments, for example, the cartridge may be used with a treatment apparatus that does not have aneye cover3016, atrigger3018, or aneyelid depressor3036. Of course some treatment apparatus may have more features than that of thetreatment apparatus3008.
• Moreover, as stated above for thecartridge957, although thecartridge3057 is shown used within a housing, it should be recognized that thecartridge3057 could be used by itself, i.e., without the housing. For example, a user could use their hand to depress theactuator3063 of thecartridge3057. Furthermore, if desired, an eyelid depressor and/or other feature(s) may be combined with thecartridge3057 in order to further assist the user in dispensing medicament. The eyelid depressor need not be trigger actuated as with theeyelid depressor3036. In some embodiments, an eyelid depressor may be integrally formed into thehousing3059 of thecartridge3057. Some other embodiments may employ an eyelid depressor that is not integral with thecartridge3057, but rather is formed separately and thereafter attached to the cartridge.
• FIGS. 54-55 show one method for providing the cartridge with an eyelid depressor. This method makes use of acap3500 that is provided with anintegral eyelid depressor3502 and is adapted to be releasably secured to thecartridge3057. In particular, thecap3500 has aperipheral wall3504 that is shaped and dimensioned to receive the end of thecartridge3057. Theperipheral wall3504 definesopenings3506 that are adapted to receive theprojections3077, which extend from thehousing3059 of thecartridge3057. This configuration allows thecap3500 to be pressed or snapped onto thecartridge3057 and/or to engage said cartridge so as to releasably secure thecap3500 to thecartridge3057. Theperipheral wall3504 of the cap further defines anopening3508 in register with thenozzle3158 so as not to block the flow of medicament delivered out of thenozzle3158.
• FIGS. 56-58 are views of the cartridge with anothercap3600 having anintegral eyelid depressor3602. Thecap3600 is similar to the cap3500 (FIGS. 54-55) except for the design of theeyelid depressor3602. Otherwise, reference numerals preceded by the numerals “36” instead of the numeral “35” indicate similar elements. As can be seen, theeyelid depressor3602 is spaced closer to the nozzle than in the previous embodiment. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the shape, configuration and/or orientation of the eyelid depressors may be adjusted as desired to achieve, for example, patient comfort, or to ensure or otherwise facilitate delivery of a drop into a predetermined region of the eye, such as the ocular cul-de-sac.
• Some other methods for providing a cartridge with an eyelid depressor are shown inFIGS. 46 and 48.
• Still other methods for releasably or fixedly securing an eyelid depressor to the cartridge should be apparent to those of ordinary skill in the art in view of the description herein.
• FIG. 59 shows one embodiment of a nozzle, piston and vial which may be used in the cartridge ofFIG. 49. Except where otherwise noted, reference numerals preceded by the numeral “4” instead of the numeral “3” indicate similar elements. This particular embodiment has twoslots4116 for the passage of fluid or other substances therethrough. The twoslots4116 are disposed diametrically opposite one another, viewed in relation to the central bore of thenozzle4158. This slot configuration produces a generally elongated spray pattern (i.e., the spray pattern of the medicament delivered from the apparatus has a somewhat elongated cross section).
• One advantage of this slot configuration is that an elongated spray pattern better conforms to the shape of the ocular cul-de-sac, as compared to that provided by a circular spray pattern. Thus, with this slot configuration, a greater percentage of medicament may be delivered into the ocular cul-de-sac, as compared to the percentage that would be delivered to the ocular cul-de-sac by a circular spray pattern is used.
• As stated above, it is often desired to direct the medicament to a particular region of the eye. In at least some embodiments, it is desirable to deliver the medicament to the cul-de-sac of the conjunctiva, sometimes referred to as the ocular cul-de-sac, which has a generally elongated shape.
• When such a slot configuration is used, keying is preferably incorporated into thecartridge3057 and/ortreatment apparatus3008 to help ensure that the generally elongated spray pattern will be generally in register with the generally elongated shape of the ocular cul-de-sac. Although not shown inFIG. 66, keying may be incorporated by providing thevial4052, or a portion thereof, with flattened side walls that are complementary to, circumferentially aligned with, and/or abut, the flattened side walls of thecartridge casing3059. See for example, the flattenedside walls1302 on the vial (FIGS. 39A,39B), which narrow the width of thevial1052 so as to enable thevial1052 to fit within the interior cavity defined by thecasing959.
• FIGS. 60A-60D are views of another embodiment of a nozzle, piston and vial that may be employed in the cartridge ofFIG. 49. Except where otherwise noted, reference numerals preceded by the numeral “5” instead of the numeral “3” indicate similar elements. This embodiment also employs two diametricallyopposed slots5116 that facilitate a generally elongated spray pattern.
• Other configurations for providing a generally elongated spray pattern will be apparent to those of ordinary skill in the art in view of the description herein.
• Notwithstanding the advantages of a generally elongated spray pattern, it should be understood that the treatment apparatus ofFIG. 49 is not limited to such spray patterns.
• Note that, except where otherwise stated, phrases such as, for example, “extends radially” mean “extends in a direction that has, but is not limited to, a radial component. Consequently, the direction may be a purely radial one or one that has a radial component in addition to an axial and/or circumferential component.
• Note that, except where otherwise stated, phrases such as, for example, “connected to” mean “connected directly to” or “connected indirectly to”. Thus, except where otherwise stated, “coupled to” means “coupled directly to” or “coupled indirectly to”.
• Also note that, except where otherwise stated, terms such as, for example, “comprises”, “has”, “includes”, and all forms thereof, are considered open-ended, so as not to preclude additional elements and/or features.
• As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present invention without departing from the spirit of the invention as defined in the claims. For example, the components of the dispensers may be made of any of numerous different materials that are currently or later become known for performing the functions of such components. Similarly, the components of the dispensers may take any of numerous different shapes and/or configurations. Also, the dispensers may be used to dispense any of numerous different types of fluids or other substances for any of numerous different applications, including, for example, ophthalmic, nasal, dermatological, or other pharmaceutical or OTC applications. Further, the sterile filling machine used to fill the dispensers of the present invention may take any of numerous different configurations that are currently, or later become known for filling the dispensers. For example, the filling machines may have any of numerous different mechanisms for sterilizing, feeding, evacuating and/or filling the dispensers. In addition, the dispensers may incorporate any of numerous different features to accommodate any of such filling machines and/or methods. Further, the pump and/or dispensing valve each may take a configuration that is different than that disclosed herein. Accordingly, this detailed description of currently preferred embodiments is to be taken in an illustrative, as opposed to a limiting sense.

Claims (4)

1. A method comprising:

providing a plurality of cartridges for storing and dispensing an ophthalmic fluid, the plurality of cartridges being substantially identical to one another and each having a vial, a pump, and a nozzle, the vial including an interior fluid receiving chamber defined therein, the pump being in fluid communication with the fluid receiving chamber for pumping a fluid received therein from the cartridge, the nozzle being disposed in fluid communication with the pump for allowing the passage of the pumped fluid therethrough, the cartridge further having a casing that retains the nozzle, the pump, and the vial arranged in that order along a longitudinal axis moving in a direction toward a posterior end of the cartridge, and an actuator operatively coupled to the pump;

installing at least one of the plurality of cartridges in an ophthalmic dispenser having an actuator to operatively couple to the cartridge, wherein actuation of the actuator initiates dispensing; and

using at least one of the cartridges to dispense ophthalmic fluid without installing the cartridge in an ophthalmic dispenser having an actuator to operatively couple to the cartridge.

2. A method comprising:

providing a plurality of cartridges for storing and dispensing an ophthalmic fluid, the plurality of cartridges being substantially identical to one another and each having a vial, a pump, and a nozzle, the vial including an interior fluid receiving chamber defined therein, the pump being in fluid communication with the fluid receiving chamber for pumping a fluid received therein from the cartridge, the nozzle being disposed in fluid communication with the pump for allowing the passage of the pumped fluid therethrough, the cartridge further having a casing that retains the nozzle, the pump, and the vial arranged in that order along a longitudinal axis moving in a direction toward a posterior end of the cartridge, and an actuator operatively coupled to the pump;

providing a plurality of dispensers adapted to receive and operate the cartridges, the plurality of cartridges being substantially identical to one another and being capable of operation as a stand alone unit or in the dispenser;

selling at least one of the cartridges in combination with at least one of the dispensers; and

selling at least one of the cartridges without a dispenser.

3. A method for filling an ophthalmic dispenser, the ophthalmic dispenser comprising: a rigid housing defining a first fluid-receiving chamber, and a flange defining a second fluid-receiving chamber axially spaced relative to the first fluid receiving chamber and connectable in fluid communication therewith; a flexible bladder defining an axially-extending body portion receivable within the first fluid-receiving chamber of the housing, a first annular sealing surface, and a second annular sealing surface axially spaced on an opposite side of the first annular sealing surface relative to the axially-extending body portion and receivable within the flange of the housing; a pump coupled in fluid communication with the first fluid-receiving chamber; a nozzle comprising a valve including an annular, axially-extending valve seat, an outlet aperture coupled in fluid communication between the valve seat and the pump, and a flexible valve cover extending about the valve seat and forming an annular, axially-extending interface therebetween, wherein the interface is connectable in fluid communication with the outlet aperture, and at least part of the valve cover is movable between (i) a normally closed position with the valve cover engaging the valve seat to close the interface and form a fluid-tight seal therebetween, and (ii) an open position with at least part of the valve cover spaced away from the valve seat in response to fluid flowing through the outlet aperture at a pressure greater than a valve opening pressure to allow the passage of pressurized fluid therebetween; and at least one spring drivingly connected to at least one of the pump and housing, wherein the spring moves at least one of the pump and housing relative to the other to actuate the pump, the method comprising the steps of:

(i) introducing an ophthalmic fluid into at least the first fluid-receiving chamber of the housing;

(ii) inserting the axially-elongated body portion of the flexible bladder at least partially into the first fluid-receiving chamber of the housing such that the first fluid receiving chamber is filled with ophthalmic fluid and at least part of the second fluid-receiving chamber is filled with ophthalmic fluid; and

(iii) forming a first substantially fluid-tight seal between the first annular sealing surface of the bladder and the housing, forming a second substantially fluid-tight seal between the second annular sealing surface of the bladder and the flange of the housing such that the first fluid-receiving chamber is filled with ophthalmic fluid substantially without any gas therein, and the second fluid-receiving chamber is at least partially filled with ophthalmic fluid.

4. A method as defined inclaim 3, further comprising the step of collapsing the flexible bladder prior to inserting the bladder into the first fluid-receiving chamber of the housing.

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